| Nr. | Date | Title |
| |
| 3685 | 08.05.2013 | Is there going to be "GMP Rating"? |
| 3674 | 08.05.2013 | Results of ECA´s Validation Survey regarding the revision of Annex 15 |
| 3672 | 08.05.2013 | Written Confirmation: Australia gets on the List of "Third Countries" |
| 3666 | 29.04.2013 | New FDA Guidance for the Prevention of Cross Contamination of Beta-Lactam Antibiotics |
| 3612 | 29.04.2013 | New USP Chapter on Inhalation Drug Products |
| 3565 | 29.04.2013 | Brazil's GMP Guideline Available in English |
| 3659 | 25.04.2013 | FDA offers eLearning for eCTD Implementation |
| 3644 | 25.04.2013 | EMA publishes Updated Procedural Advice for Centralised Marketing Authorisations |
| 3610 | 25.04.2013 | CTD Format for Traditional Herbal Medicinal Products |
| 3669 | 24.04.2013 | Revision of the EU GMP Guide: EU Commission Proposal for Chapter 6 - Quality Control |
| 3663 | 24.04.2013 | EudraGMP Database now also comprises GDP Information |
| 3651 | 24.04.2013 | Written Confirmations: Questions & Answers Document Version 4.1 published! |
| 3647 | 24.04.2013 | FDA Guidance for Industry on Validation of Blood Establishment Computer Systems |
| 3654 | 17.04.2013 | Written Confirmations: Time is running out - new EU Progress Report |
| 3648 | 17.04.2013 | Change Control: New SUPAC Guidance published |
| 3640 | 17.04.2013 | Comparison of EU GMP and Indian GMP Requirements for APIs |
| 3606 | 17.04.2013 | Quality Standards on Recovered Solvents in the Manufacture of Herbal Medicinal Products |
| 3635 | 10.04.2013 | FDA publishes GMP Requirements for "Combination Products" |
| 3615 | 10.04.2013 | Sample Documentation on EU Site Master File published |
| 3599 | 10.04.2013 | How many Validation Runs are State-of-the-Art today? |
| 3566 | 10.04.2013 | Harmonisation of Bacterial Endotoxin Testing - ICH guideline Q4B Annex 14 |
| 3621 | 09.04.2013 | FDA publishes Draft on Medical Devices Recalls Guideline |
| 3613 | 09.04.2013 | GMP for Medical Devices - ANVISA's Inspection Guide |
| 3575 | 09.04.2013 | FDA's Strategies on the Regulation of Medical Products: How do they look like? |
| 3526 | 09.04.2013 | How are FDA GMP Guidelines on the Regulation of Medical Devices made? |
| 3641 | 04.04.2013 | Written Confirmations - How is the EU pharmaceutical Industry dealing with that? |
| 3608 | 04.04.2013 | Future Quality Requirements on Essential Oils in Europe |
| 3604 | 04.04.2013 | MHRA implements new Software for risk based Inspection Planning |
| 3595 | 04.04.2013 | FDA Warning Letter on Water Purification |
| 3634 | 03.04.2013 | Simplification of Application Submissions for Centrally Authorised Products |
| 3629 | 03.04.2013 | WHO's New Draft Guideline on Submission of Quality Data for Generic Medicinal Products |
| 3630 | 27.03.2013 | India issues Guidelines for Certification of API Exports to EU - can the EU accept this Certification? |
| 3628 | 27.03.2013 | Second Publication of PDA's Technical Report on Process Validation |
| 3624 | 27.03.2013 | Updated on Implementation of the Counterfeit Directive 2011/62 in the EU Countries |
| 3593 | 27.03.2013 | New WHO Guideline on the Establishing of Hold Times of Intermediate and Bulk Products |
| 3598 | 21.03.2013 | Safety of Blood Components for Transfusion and of Stem Cell Products: Testing for HIV, HBV and HCV |
| 3597 | 21.03.2013 | FDA Recommendations for Syphilis Screening of Blood and Blood Components |
| 3596 | 21.03.2013 | Technical Update of Inspection of Licensed and Unlicensed Blood Banks, Brokers, Reference Laboratories, and Contractors |
| 3625 | 20.03.2013 | New Information on Written Confirmation from the EU Commission |
| 3619 | 20.03.2013 | Revision of the GMP Matrix: US GMP vs. EU GMP |
| 3586 | 20.03.2013 | Validation on the move: How should the Annex 15 of the EU GMP Guide be revised? |
| 3259 | 20.03.2013 | Where can Indications on the Riboflavin Test be found? Are there any alternatives? |
| 3603 | 12.03.2013 | Final Good Distribution Practices (GDP) Guideline published by EU Commission |
| 3520 | 12.03.2013 | Why is GMP so important - Answers from the FDA |
| 3434 | 12.03.2013 | AQL testing in the visual inspection of parenterals (FAQs) |
| 3585 | 06.03.2013 | FDA seeks getting on the List of Third Countries with equivalent GMP Standards |
| 3584 | 06.03.2013 | China Publishes New Good Distribution Practices |
| 3578 | 06.03.2013 | ICH publishes New Draft Guideline on Genotoxic Impurities |
| 3560 | 28.02.2013 | EDQM restricts the Acceptance of Substances for New CEP Applications |
| 3443 | 28.02.2013 | European Medicines Agency recommends approval of first vaccine for meningitis B |
| 3589 | 27.02.2013 | Are 300 GMP Inspections necessary by 2 July 2013? |
| 3576 | 27.02.2013 | MHRA and NIBSC get new Structure on 1 April 2013 |
| 3432 | 27.02.2013 | FAQs concerning the visual inspection of Parenterals |
| 3557 | 20.02.2013 | Good Distribution Practices for APIs - EU Commission Publishes Draft Guideline |
| 3548 | 20.02.2013 | European Commission Publishes Extended Question/Answer Document on Written Confirmation |
| 3535 | 20.02.2013 | India opens Drug Inspection Office in China |
| 3506 | 20.02.2013 | SFDA rewards Whistleblowers |
| 3573 | 18.02.2013 | Starting Materials and Intermediates |
| 3572 | 18.02.2013 | Risk-based Approach to Advanced Therapy Medicinal Products |
| 3571 | 18.02.2013 | Warning on transmissible Agents |
| 3570 | 18.02.2013 | Isolation of Candidate Influenza Vaccine Viruses in Cell Culture |
| 3569 | 18.02.2013 | Recombinant and Human Plasma-derived Factor IX Products |
| 3568 | 18.02.2013 | Recombinant and Human Plasma-derived Factor VIII Products |
| 3567 | 18.02.2013 | Plasma-derived Medicinal Products |
| 3555 | 14.02.2013 | New EU Template for QP Declaration (IMPs) |
| 3541 | 14.02.2013 | New Eudralex Vol.10 Guidance |
| 3521 | 14.02.2013 | EMA issues Concept Paper for Antimicrobial Resistance Risk Assessment Guideline |
| 3513 | 14.02.2013 | Responses to the public Consultation on the Paediatric Regulation |
| 3511 | 14.02.2013 | New Guidance for Recall of IMPs |
| 3486 | 14.02.2013 | FDA publishes List of planned Guidances for Medical Devices |
| 3471 | 14.02.2013 | Regulatory Requirements concerning Quality Assurance of Medical Devices in Japan |
| 3468 | 14.02.2013 | China-Europe: Information on Standards and Market Requirements |
| 3553 | 13.02.2013 | Guidelines for formalised Risk Assessment of pharmaceutical Excipients issued |
| 3538 | 13.02.2013 | Laboratory Data Integrity in FDA Warning Letters 2012 |
| 3537 | 13.02.2013 | WHO GMP approaching EU-GMP |
| 3523 | 13.02.2013 | Up to $190.389 for FDA's New Inspections Fees |
| 3503 | 13.02.2013 | Discussion of elemental Impurities in pharmaceutical Water |
| 3530 | 06.02.2013 | Cross-contamination: Topic of the Revisions of Chapters 3 and 5 EU GMP Guideline |
| 3515 | 06.02.2013 | PDA publishes Technical Report on Cleaning Validation |
| 3507 | 06.02.2013 | Outcome of the public Consultation on the Review of the Variations Guidelines |
| 3495 | 06.02.2013 | India Preparing for the Issuance of Written Confirmations |
| 3478 | 06.02.2013 | New: ICH Q4B - Annex 13 on the Density of Powders |
| 3528 | 30.01.2013 | Comparison (Matrix) of Former vs New Version of Chapter 1 of the EU GMP Guide Part 1 Effective from 31/01/2013 |
| 3509 | 30.01.2013 | Revision of Chapter 8 of the EC guide to GMP (Complaints and Recalls) |
| 3499 | 30.01.2013 | New EMA Guideline on Dedicated Facilities and Exposure Limits for Cleaning Validation |
| 3475 | 30.01.2013 | ECA Analytical Quality Control Working Group - Final OOS SOP |
| 3500 | 29.01.2013 | FDA publishes three Guidances to facilitate Assessment/Submission of Medical Devices |
| 3493 | 29.01.2013 | FDA publishes Draft Guidance on Design of Medical Devices |
| 3483 | 29.01.2013 | GHTF ceases to work |
| 3518 | 23.01.2013 | Revision of the EU GMP Guide: EU Commission Publishes Proposals for Chapters 3, 5, 6 and 8 |
| 3481 | 23.01.2013 | New GAMP Guide for Laboratory Computerized Systems |
| 3474 | 23.01.2013 | USP plans Revision of General Notices Section of the Pharmacopoeia |
| 3470 | 23.01.2013 | ICH Develops Another Pre-Step 2 Q3D Draft to Strengthen Consensus on Heavy Metal Standards |
| 3491 | 17.01.2013 | FDA - Annual Fatalities Report FY2011 |
| 3490 | 17.01.2013 | FDA Study Confirms Suitability of Plasma for Nucleic Acid Testing (NAT) of Blood Donations for Hepatitis C Virus |
| 3489 | 17.01.2013 | Measures to reduce the Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease |
| 3488 | 17.01.2013 | Recommendations for Donor Questioning, Deferral, Reentry and Product Management |
| 3487 | 17.01.2013 | Pre-Storage Leukocyte Reduction |
| 3485 | 17.01.2013 | Use of Nucleic Acid Tests |
| 3464 | 16.01.2013 | New MHRA Q & A Document on the Import of Active Pharmaceutical Ingredients |
| 3455 | 16.01.2013 | EMA publishes Reflection paper on Supply Shortages caused by Manufacturing/Good Manufacturing Practice Compliance Problems |
| 3454 | 16.01.2013 | New EMA Guideline for Products with modified Active Substance Release |
| 3452 | 16.01.2013 | Analytical Balances: New USP Proposals on Qualification |
| 3448 | 09.01.2013 | Swissmedic - Information about the Plasma Master File in Switzerland |
| 3445 | 09.01.2013 | CDER publishes "Review" of the Year 2012 |
| 2938 | 09.01.2013 | Significant Guidelines regarding Veterinary Medicinal Products |
| 3450 | 19.12.2012 | New Method to Directly Sequence Small Genomes Without Library Preparation |
| 3449 | 19.12.2012 | New USP Publication: Monitoring Humidity during Transportation? |
| 3442 | 19.12.2012 | PIC/S issues Update of GMP Guide |
| 3421 | 12.12.2012 | Swiss GMP standards and inspection equivalent to EU |
| 3394 | 12.12.2012 | FDA provides information about influence of wheather conditions on biological products |
| 3428 | 05.12.2012 | USP Postpones the Publication of General Chapters <232> and <233> on Metallic Impurities |
| 3426 | 05.12.2012 | EMA publishes Concept Paper on the Revision of Annex 15 |
| 3423 | 05.12.2012 | New Concept Paper on Annex 17 of the EU GMP Guide |
| 3419 | 28.11.2012 | Pharmaceutical Standards in Israel and EU Equivalents |
| 3415 | 28.11.2012 | ECA publishes Good Practice Guide on Process Validation |
| 3411 | 28.11.2012 | How to Manage Efficiently Annual GMP Trainings? |
| 3412 | 21.11.2012 | FDA-approval for Roche’s nucleic acid based (PCR) Rapid Mycoplasma Test (MycoTOOL® PCR Mycoplasma Detection Kit) |
| 3408 | 21.11.2012 | ICH plans Q&A on ICH Q7 |
| 3404 | 21.11.2012 | New guideline for DNA Sequences could prevent erroneous Data |
| 3403 | 21.11.2012 | News from the PIC/S |
| 3382 | 21.11.2012 | Revision of USP 1223 - current Status |
| 3413 | 20.11.2012 | Rapid Micro Biosystems announces Availability of Growth Direct System |
| 3393 | 15.11.2012 | EMA announces streamlining of activities of Committee for Advanced Therapies |
| 3323 | 15.11.2012 | Commitee for Advanced Therapy Medicinal Products (CAT) - Public Call for Expression of Interest |
| 3407 | 14.11.2012 | New EMA Q&As on Genotoxic Impurities |
| 3399 | 14.11.2012 | Medical Devices Warning Letter Statistics 2012 - Rank 1 for CAPA and Complaint Files |
| 3366 | 14.11.2012 | New EU-GMP Chapter calls for Continuous Improvement |
| 3396 | 07.11.2012 | Changes to Variation Rules started to apply |
| 3391 | 07.11.2012 | New EMA Guideline on Specifications for Impurities in Antibiotics |
| 3388 | 07.11.2012 | GMP Compliance Problems may cause Drug Shortages |
| 3345 | 06.11.2012 | EMA Assessment Report - on detected genomic fragments from endogenous and adventitious viral agents in live attenuated vaccines |
| 3337 | 06.11.2012 | Literature and publications list are updated with 11 publications |
| 3336 | 06.11.2012 | RMM database updated with new systems |
| 3386 | 31.10.2012 | EU Commission publishes Version 2.0 of the Question and Answer Document on API Importation |
| 3381 | 31.10.2012 | WHO issues Update of Pharmaceutical Water Guideline |
| 3374 | 31.10.2012 | DataMatrix Code on Pharmaceutical Packaging - Pilot Project starting in January |
| 3365 | 30.10.2012 | Modification of ISO 13485 - new Annexes ZA, ZB and ZC |
| 3364 | 30.10.2012 | QP for Manufacturers of Medical Devices - New EU Requirement? |
| 3353 | 30.10.2012 | New rules for Medical Devices published by the EU - significantly tightened Controls planned |
| 3376 | 24.10.2012 | FDA Warning Letter Statistics 2011 with regard to Process Validation / Qualification and Calibration |
| 3370 | 24.10.2012 | EMA on Track to meet Targets |
| 3362 | 24.10.2012 | Draft Guideline on Good Distribution Practices for Biological Products published by CDSCO |
| 3369 | 17.10.2012 | WHO publishes revised Draft Guideline on Quality Risk Management |
| 3357 | 17.10.2012 | Additional Guidance Document on Active Substance Master File (ASMF) published by EMA |
| 3355 | 17.10.2012 | FDA requires Registration of Manufacturing Facilities until December 2, 2012 |
| 3264 | 17.10.2012 | Handling of Deviations and CAPA criticised by Inspectorates |
| 3344 | 11.10.2012 | FDA publishes Draft Guidance on Stability Testing of Generics |
| 3342 | 11.10.2012 | Generic Drug Applications in the USA: Completeness Assessment of Drug Master Files for APIs by the FDA |
| 3332 | 10.10.2012 | GMP Matrix as Standard for Audits in many Companies |
| 3290 | 10.10.2012 | Questions and Answers of the Japanese Regulatory Authorities regarding Computerized Systems |
| 2933 | 10.10.2012 | What are the consequences if an API manufacturer has not been audited? |
| 3350 | 09.10.2012 | US Government Report on Innovation in Pharmaceutical Development |
| 3347 | 09.10.2012 | European Commission seeks Feedback on Paediatric Regulation |
| 3346 | 09.10.2012 | Update of FDA Clinical Investigator Inspection List |
| 3330 | 04.10.2012 | Which Types of Third Party GMP Audits may be used - which not? |
| 3324 | 04.10.2012 | Chinese API Manufacturers revealed to have used gutter oil for the Manufacture of Antibiotics |
| 3311 | 04.10.2012 | Qualified Person Association Database for Shared Audits "QPSHARE" comprises 284 API and Excipient Suppliers |
| 3306 | 04.10.2012 | ISPE Guide bridges traditional Qualification and risk- and science-based Qualification |
| 3310 | 01.10.2012 | FDA confirms Deadline for Application of QbD for Generic Drug Manufacturers! |
| 3298 | 01.10.2012 | FDA Dissolution Methods Database |
| 3278 | 01.10.2012 | Interesting Case Study on Quality by Design for Vaccines |
| 3274 | 01.10.2012 | EMA explains EU Incident Management Plan for Human Medicines |
| 3255 | 01.10.2012 | EMA recommends first Gene Therapy for Approval |
| 3318 | 27.09.2012 | The new EU GMP Chapter 1 in Pharmaceutical Development |
| 3304 | 27.09.2012 | FDA Requirements on Bioequivalence Data for Generic Drug Products |
| 3325 | 26.09.2012 | EU: new Delegated Act on Shipments of Medicinal Products through EU |
| 3307 | 26.09.2012 | The new EU Good Distribution Practices (GDP) Guideline - What will happen next? |
| 3295 | 26.09.2012 | ISPE Mapping Document explains Relationship between different Qualification Guides |
| 3335 | 19.09.2012 | The new EU GMP Guide Annex 2 - a brief Content Summary |
| 3328 | 19.09.2012 | Extension of Directive 2003/94/EC to GMP for APIs - EU Commission publishes Comments on Concept Paper |
| 3302 | 19.09.2012 | Dissolution Testing of new and special Dosage Forms - Updated FIP/AAPS Document |
| 3292 | 19.09.2012 | EMA raises Concerns regarding Sterility Assurance for DepoCyte and gives Recommendations |
| 3289 | 19.09.2012 | Actual GMP Deficiencies concerning Validation/Qualification/Calibration as seen by the MHRA |
| 3287 | 19.09.2012 | Japanese Requirements on Computerised Systems |
| 3265 | 19.09.2012 | cGMP: SOP Management and Training criticised by FDA |
| 3320 | 12.09.2012 | Finally published: new EU GMP Chapter 7 on Outsourced Activities |
| 3316 | 12.09.2012 | Finally published: new EU GMP Chapter 1 with comprehensive Changes |
| 3315 | 12.09.2012 | GMP Guideline Annex 2 revised |
| 3300 | 12.09.2012 | USP Standard for Dissolution Testing withdrawn |
| 3263 | 12.09.2012 | ICH Q8, Q9, & Q10 Questions and Answers - now also in force in the USA |
| 3285 | 05.09.2012 | FDA publishes Proposals on Harmonised Identification of Medical Devices (UDI) |
| 3270 | 05.09.2012 | Chinese SFDA issues new Regulation on a strengthened Supervision of Pharmaceutical Excipients' Manufacturers |
| 3284 | 04.09.2012 | IEC 60601-1 valid in 3rd Version since June 2012 - Risk Management playing important Role |
| 3283 | 04.09.2012 | Will there be a Registration Obligation for critical Medical Devices? |
| 3281 | 04.09.2012 | New Guide for Manufacturers of Stand Alone Software |
| 3268 | 30.08.2012 | Novel Manufacturing Strategy: Continuous Manufacturing - Development Case Study |
| 3271 | 29.08.2012 | New Templates for GMP and GDP certificates published by EMA |
| 3261 | 22.08.2012 | Continuous Manufacturing - FDA Perspective on Submissions and Implementation |
| 3253 | 22.08.2012 | Curved Calibration Functions - how to perform the Regression Calculation? |
| 3240 | 22.08.2012 | FDA Expectations concerning Real Time Release Testing (RTRT) |
| 3238 | 22.08.2012 | New EMA draft on NIRS |
| 3226 | 22.08.2012 | USP Article about new USP NIR System Suitability Reference Standard |
| 3215 | 22.08.2012 | New EMA Guideline on Real Time Release Testing |
| 3254 | 15.08.2012 | FDA Warning Letters relating to Computerised Systems |
| 3241 | 15.08.2012 | EMA publishes Video explaining the new Pharmacovigilance Legislation |
| 3250 | 14.08.2012 | New Rules for the Importation of APIs - a European Commission Leaflet provides Information |
| 3249 | 14.08.2012 | Dr. Claudius Micha Nübling becomes Member of the RMM Group Advisory Board |
| 3248 | 14.08.2012 | New Additions to the Literature List on ECA's RMM Website |
| 3247 | 14.08.2012 | Rapid Methods - CBER's Strategic Plan for Regulatory Science and Research |
| 3243 | 14.08.2012 | More Flexibility in Sterility Testing of biologic Products – FDA Amendments |
| 3235 | 14.08.2012 | Draft on New GCP Directive 2001/20/EG |
| 3231 | 14.08.2012 | EDQM publishes Guidance on Notifications of Changes of CEPs |
| 3218 | 14.08.2012 | GDUFA: New Fee Act for the Generic Drugs and APIs Industry adopted by the Congress |
| 3210 | 14.08.2012 | ATMP - EMA Reflection Paper on Classification of Advanced Therapy Medicinal Products |
| 3209 | 14.08.2012 | Revised Guideline on Renewals in the Centralised Procedure Effective! |
| 3204 | 14.08.2012 | FDA Approves OTC HIV Test for the First Time |
| 3202 | 14.08.2012 | FDA publishes Q&A Guidance on Endotoxin and Pyrogen Testing |
| 3197 | 14.08.2012 | FDA issued 8 Warning Letters to Companies because of Missing Establishment Registration |
| 3190 | 14.08.2012 | Will there be an Authorisation Obligation for Critical Medical Devices? |
| 3123 | 14.08.2012 | New Homepage of ECA's Rapid Microbiological Methods Working Group |
| 3122 | 14.08.2012 | ECA's Rapid Microbiological Methods Conference |
| 3121 | 14.08.2012 | Case Study of New Growth-based Rapid Microbiological Method (RMM) detects the Presence of Specific Organisms |
| 3233 | 01.08.2012 | Top 10 Deficiencies - Applications for Certificates of Suitability (CEP) |
| 3227 | 01.08.2012 | Revised Guideline on the ASMF Procedure Coming into Force on 1st October 2012 |
| 3219 | 01.08.2012 | Another Third Party GMP Audit performed in Germany by API Compliance Institute |
| 3229 | 25.07.2012 | Continuing Trend: Again, Numerous Warning Letters issued to European API Manufacturers |
| 3222 | 25.07.2012 | More GMP Inspections by EMA due to Increasing Quality Issues |
| 3207 | 25.07.2012 | How to set Specifications for Genotoxic, Metallic Impurities and Residual Solvents in APIs? |
| 3200 | 25.07.2012 | New Guide for Manufacturers of Stand Alone Software |
| 3211 | 11.07.2012 | EU GMP Part 3: New Final Document on Written Confirmation |
| 3192 | 11.07.2012 | USP's Position to the Glass Particles Issue |
| 3187 | 11.07.2012 | FDA - S6 Preclinical Safety Evaluation of Biotechnology-Derived Pharmaceuticals |
| 3186 | 11.07.2012 | FDA issues Amendment to the Guidance for Industry: Revised Preventive Measures to Reduce the Possible Risk of Transmission of Creutzfeldt-Jakob Disease and Variant Creutzfeldt-Jakob Disease by Blood and Blood Products |
| 3194 | 04.07.2012 | New Guidelines on Good Pharmacovigilance Practices released |
| 3189 | 04.07.2012 | MHRA publishes GMP Deficiency Data Review April 2011 - March 2012 |
| 3184 | 04.07.2012 | USP Chapter <62> Frequently Asked Questions |
| 3185 | 27.06.2012 | FDA Study Confirms Suitability of Plasma for Nucleic Acid Testing (NAT) of Blood Donations for Hepatitis C Virus |
| 3167 | 27.06.2012 | APIs from China and India - will Import go down in 2013? |
| 3180 | 20.06.2012 | Revision of the Guidelines on Category Variations to the terms of Marketing Authorisations- EU Commission releases Public Consultation Paper |
| 3174 | 20.06.2012 | EMA updates "Compilation of Community Procedures on Inspections and Exchange of Information" |
| 3169 | 20.06.2012 | Audit Tools and Checklists for Good Distribution Practices |
| 3166 | 20.06.2012 | Revised Guideline Draft on Biosimilar Medicinal Products published |
| 3163 | 13.06.2012 | News PIC/S Structure |
| 3157 | 13.06.2012 | FDA starts Voluntary Audit Report Program for Medical Devices |
| 3134 | 13.06.2012 | Two Third Party GMP Audits performed in Germany by API Compliance Institute |
| 3006 | 13.06.2012 | FDA identifies 22 Chinese companies out of GMP compliance |
| 3160 | 06.06.2012 | Half-year Report 2012: FDA Medical Devices Warning Letter Statistics |
| 3155 | 06.06.2012 | Important Notice from the EDQM to CEP Holders - Warning of Fraudulent Invoices |
| 3152 | 06.06.2012 | EMA: Practical Guidance on Implementation of Pharmacovigilance Legislation published |
| 3151 | 06.06.2012 | New IMPD Guideline on the Requirements for Quality Documentation concerning Biological Investigational Medicinal Products in Clinical Trials |
| 3058 | 05.06.2012 | New USP Chapter <1083> on Good Distribution Practices |
| 3052 | 05.06.2012 | GMP Requirements for Pharmaceutical Excipients: NSF International publishes new Draft Standard |
| 3038 | 05.06.2012 | FDA publishes Draft Guidance on Clinical Studies for Medical Devices |
| 3035 | 05.06.2012 | FDA's new Guidance Documents for 2012 |
| 3149 | 30.05.2012 | Current State of Harmonisation (EP/USP/JP) |
| 3146 | 30.05.2012 | Rx-360 releases New Checklists |
| 3144 | 30.05.2012 | Quality documentation concerning biological investigational medicinal products in clinical trials |
| 3142 | 30.05.2012 | Incorrect Handling of OOS Results found in 10 FDA Warning Letters in 2011 |
| 3143 | 23.05.2012 | OOS Results - Very helpful Q&As published on the MHRA Website |
| 3131 | 23.05.2012 | New Developments at EP, USP an JP - Divergent Compendial Methods and Harmonisation |
| 3116 | 23.05.2012 | New ECA Working Group on Process Validation starts first Project |
| 3112 | 23.05.2012 | Detailed Analysis of EMA's new Draft on Process Validation |
| 3141 | 16.05.2012 | Development and Manufacturing of APIs: Final ICH Q11 Document Published! |
| 3133 | 16.05.2012 | New USP Chapter on Method Transfer effective |
| 3130 | 16.05.2012 | Which Information on Stability of Pharmaceutical Bulk Products is required in the Application Dossier? |
| 3127 | 16.05.2012 | Foundation of a new French Health Regulation Authority |
| 3120 | 16.05.2012 | Interesting USP Validation Documents - Available Online free of Charge! |
| 3101 | 16.05.2012 | EMA strengthens Oversight on Clinical Trials outside EU |
| 3086 | 16.05.2012 | EMA - Regulatory procedural Advice on similar biological medicines |
| 3113 | 09.05.2012 | FDA Compliance Programme Guidance on Inspections of Medical Devices Manufacturers |
| 3111 | 09.05.2012 | The new EMA's eSubmission Gateway for Centralised Authorisations is released! |
| 3093 | 09.05.2012 | New GAMP Good Practice Guide for Risk-Based Approach to GxP Compliant Laboratory Computerised Systems: Due for Publication in June |
| 3090 | 09.05.2012 | FDA Update |
| 3109 | 03.05.2012 | Import of APIs from Third Countries into the European Union: Template for the written Confirmation of GMP Compliance published for Comments |
| 3107 | 03.05.2012 | New EMA Questions and Answers Document on Post Approval Change Management Protocols |
| 3083 | 03.05.2012 | FDA amends wording in the CFR for Label Control Provisions for certain Label Types |
| 3079 | 03.05.2012 | FDA wants to facilitate Drug Development with new Tools |
| 3012 | 03.05.2012 | New FDA Online Training on GMP for Medical Devices |
| 3099 | 25.04.2012 | Several API manufacturers in China, India and Brazil found out of GMP compliance |
| 3098 | 25.04.2012 | EMA publishes Draft on the Process Validation Guideline |
| 3096 | 25.04.2012 | Interesting FDA Presentation on Supply Chain Integrity |
| 3085 | 25.04.2012 | Maintaining Laboratory Computer Validation - How to Conduct Periodic Reviews? |
| 3075 | 25.04.2012 | Questions & Answers on EU GMP Guideline Annex 11 "Computerised Systems" - chapter 4 |
| 3084 | 18.04.2012 | Track & Trace: SecurPharm Pilot Project now also considers the GS1 Standard |
| 3074 | 18.04.2012 | Questions & Answers on EU GMP Guideline Annex 11 "Computerised Systems" - chapter 3 |
| 3070 | 18.04.2012 | How to Implement Design Control for Combination Products within Pharma? |
| 3066 | 18.04.2012 | EU Clinical Trials Register in co-operation with WHO |
| 3082 | 11.04.2012 | FDA: Ensuring the Safety of Vaccines in the United States |
| 3078 | 11.04.2012 | PIC/S publishes Aide-Memoire on Inspection of Risk Management Systems |
| 3072 | 11.04.2012 | Questions & Anwers on EU GMP Guideline Annex 11 "Computerised Systems" - chapters 1-2 |
| 3065 | 11.04.2012 | New EMA Reflection Paper on Heparin and further Biological Starting Materials |
| 3063 | 04.04.2012 | Significant Changes in HPLC System Suitability: New USP Provisions Planned |
| 3060 | 04.04.2012 | American Pharmaceutical Association suggests its own Model for Track and Trace |
| 3045 | 04.04.2012 | The new role of the Responsible Person for Good Distribution Practices |
| 3033 | 04.04.2012 | International Collaboration on Good Manufacturing Practice Inspections expanded |
| 3051 | 21.03.2012 | The EDQM eTACT Project for an Anti-Counterfeiting Traceability Service for Medicines |
| 3041 | 21.03.2012 | Data Integrity Problems as key Issue for Ranbaxy's Consent Decree |
| 3032 | 21.03.2012 | New Requirements for the Submission of Information on Medicinal Products - EMA publishes New Guidance for MAHs and a revised "Legal Notice" |
| 3013 | 21.03.2012 | ISPE Guide assists modern Qualification |
| 3030 | 14.03.2012 | Regulatory Monitoring of API Manufacturers - FDA, TGA, EMA and EDQM express Common Objectives for Inspections Collaboration |
| 3027 | 14.03.2012 | Transitional Regulations for the New Pharmacovigilance Package: Commission's Q&A Document provides Clarity |
| 3022 | 14.03.2012 | FDA's new web-based Training explains FDA Drug Regulatory Work |
| 2991 | 14.03.2012 | PIC/S asks Inspectors to have a look at Job Cuts |
| 3025 | 07.03.2012 | EMA Reflection Paper on Sourcing Biological Starting Materials |
| 2994 | 07.03.2012 | How to Integrate Analytical Instrument Qualification and Computerised System Validation? |
| 2978 | 07.03.2012 | FDA - New draft guidances for Biosimilars |
| 2953 | 07.03.2012 | New Chinese GMP rules published in English |
| 2998 | 29.02.2012 | HPLC in FDA Warning Letters |
| 2986 | 29.02.2012 | FDA Draft Guidance: How to qualify Heparin Suppliers |
| 2981 | 29.02.2012 | Safety Features & Drug Authentication: Which System will prevail? |
| 2974 | 29.02.2012 | Bio Assays - Commentary – First Supplement to USP 35-NF 30 |
| 2983 | 22.02.2012 | Medical Devices: European Commission calls for Immediate Actions - Tighten Controls, Increase Surveillance |
| 2976 | 22.02.2012 | EMA works on Recalculation of Limits for Cleaning Validation |
| 2972 | 22.02.2012 | EU Commission publishes Feedback on New Good Distribution Practices (GDP) Guide |
| 2960 | 22.02.2012 | FDA Generic Drugs Office Advances QbD, Review Processes and QM System in Anticipation of User Fees |
| 2968 | 15.02.2012 | Revision of the European Variations System: EU Commission publishes the Outcome of the Public Consultation |
| 2963 | 15.02.2012 | EMA counts down to Introduction of new Pharmacovigilance Legislation |
| 2940 | 15.02.2012 | Publication of the Danish Medicines Agency about Requirements regarding Updates of Active Substance Master Files |
| 2922 | 15.02.2012 | Overview of FDA Warning Letters regarding the Manufacture of Sterile Medicinal Products |
| 2898 | 15.02.2012 | EMA Guideline on Quality of Herbal Medicinal Products Updated |
| 2861 | 15.02.2012 | ECA Analytical Quality Control Working Group - Final OOS SOP |
| 2969 | 08.02.2012 | EXCiPACT - A new Certification Scheme for Excipients has been launched |
| 2966 | 08.02.2012 | New Questions and Answers about the Centralised Procedure - EMA publishes an Updated Q&A Document |
| 2947 | 08.02.2012 | Good Distribution Practices (GDP) adopted by PIC/S |
| 2945 | 08.02.2012 | Joint Statement of the EFPIA, GIRP and PGEU regarding Falsified Medicines |
| 2901 | 08.02.2012 | New EMA Guideline on Specifications for Herbal Medicinal Products |
| 2958 | 01.02.2012 | GMP for Medical Devices - Lessons learnt from the PIP Scandal? |
| 2952 | 01.02.2012 | Significant Administrative Changes in the New Revision of the Guideline on the ASMF Procedure |
| 2949 | 01.02.2012 | FDA: QbD becomes mandatory for Generics |
| 2942 | 25.01.2012 | Extension of Directive 2003/94/EC to GMP for APIs - EC Commission publishes Concept Paper for Comment |
| 2932 | 25.01.2012 | Short-term Revision of USP Chapter on Dissolution Testing |
| 2917 | 25.01.2012 | Pharmeuropa publishes a Draft Monograph on "Biological Indicators" |
| 2899 | 25.01.2012 | Report of the HMPC Meeting held in November 2011 |
| 2930 | 18.01.2012 | Inadequate Validation of Analytical Methods remains permanent Topic in Warning Letters to API Manufacturers |
| 2915 | 18.01.2012 | Archiving of Paper and Electronic Data of great Concern for FDA and EU Authorities |
| 2895 | 18.01.2012 | New ISPE Guide on Process Gases |
| 2924 | 12.01.2012 | GMP non-Compliance causes further CEP Suspensions |
| 2909 | 12.01.2012 | New Version of ISO 19011 on Auditing published |
| 2905 | 12.01.2012 | ICH Q11 close to final Approval |
| 2904 | 12.01.2012 | EMA, CVMP - Testing of Mycoplasma Contamination |
| 2906 | 03.01.2012 | IPEC publishes GDP Audit Guideline for Pharmaceutical Excipients |
| 2891 | 03.01.2012 | Drug Master Files (DMF) - Recorded Webinar with FDA Dr Arthur B. Shaw |
| 2877 | 03.01.2012 | USP elaborates Guidelines to limit Counterfeit Medicines |
| 2889 | 21.12.2011 | IMB publishes Guide on GDP (wholesale distribution) |
| 2887 | 21.12.2011 | New FDA and EMA Initiative allows mutual Recognition of Inspections |
| 2885 | 14.12.2011 | ICH Publishes Additional Q8/Q9/Q10 Points to Consider |
| 2883 | 14.12.2011 | Anti-Counterfeiting Directive requires Import Certificate for the Import of APIs from Third Countries into the EU |
| 2868 | 14.12.2011 | Screening of Frequent Donors of Blood and Blood Components |
| 2866 | 07.12.2011 | New Concept Paper of the European Commission on the Use of Safety Features against Falsified Medicinal Products |
| 2863 | 07.12.2011 | Archiving of Chromatograms: FDA provides important Clarification |
| 2859 | 07.12.2011 | CEP Suspensions and Withdrawal due to GMP Deviations |
| 2874 | 30.11.2011 | USP publishes First Ten Quality Standards in New Medicines Compendium |
| 2872 | 30.11.2011 | "Production Record Review" - The most frequently cited Paragraph in FDA Warning Letters |
| 2870 | 30.11.2011 | Twelve Countries sign Medicrime Convention on Counterfeit Medicines |
| 2867 | 30.11.2011 | FDA wants to streamline the Classification of Blood and Plasma Recalls |
| 2856 | 23.11.2011 | EMA publishes Concept Paper on Dedicated / Shared Facilities |
| 2678 | 23.11.2011 | WHO issues revised version of HVAC Guide |
| 2851 | 16.11.2011 | New Concept paper on Annex 16 of the EU-GMP Guide |
| 2848 | 16.11.2011 | FDA publishes Q8/Q9/Q10 Implementation Document |
| 2831 | 16.11.2011 | FDA Guideline on Anticounterfeiting Medicines |
| 2843 | 09.11.2011 | European Pharmaceutical Industry presents its Expectations to the EU Note for Guidance on Process Validation |
| 2840 | 09.11.2011 | New QP Declaration for managing Expiry Dates of IMPs |
| 2838 | 09.11.2011 | MHRA announces Good Clinical Practice (GCP) Discussion Forum |
| 2837 | 09.11.2011 | Medical Devices Warning Letter Statistics 2011 |
| 2834 | 02.11.2011 | International Information Sharing is Impacting FDA Inspection and Enforcement Decision-Making |
| 2818 | 02.11.2011 | First ECA/EQPA Conference in the U.S. a great Success |
| 2815 | 02.11.2011 | FDA Inspectional Observations on Hygiene, Cleaning and Sanitation |
| 2808 | 02.11.2011 | GHTF publishes Guidance on Globally Harmonised Identification of Medical Devices |
| 2825 | 26.10.2011 | FDA Draft Guidance regarding Media Fills for PET Drugs |
| 2822 | 26.10.2011 | FDA defines 25 SOP provisions required by CFR |
| 2821 | 26.10.2011 | FDA publishes List of Guidance Documents for Medical Devices |
| 2811 | 26.10.2011 | CHMP adopts Guideline on Quality Aspects on the Isolation of Candidate Influenza Vaccine Viruses |
| 2828 | 20.10.2011 | EU Commission publishes a New Document about Duplicate Marketing Authorisation Applications |
| 2809 | 20.10.2011 | FDA strives for more Transparency regarding GMP Compliance and Enforcement Data |
| 2800 | 20.10.2011 | FDA Q&As on pathogenic Contamination of animal-derived Drug Ingredients |
| 2724 | 20.10.2011 | Summary of FDA 483 Inspectional Observations |
| 2772 | 13.10.2011 | Activities of the USP Microbiology and Sterility Assurance Expert Committee During the 2005-2010 Revision Cycle |
| 2753 | 12.10.2011 | Technical Report - Assistance for Biotechnology Cleaning Validation |
| 2806 | 05.10.2011 | EMA Reflection Paper provides Concrete Information about Risk based Quality Management |
| 2802 | 05.10.2011 | Extension of the Variations Regulation to Purely National Authorisations coming: new Consultation Paper published by the EU Commission |
| 2777 | 05.10.2011 | New FDA Requirements regarding Tablet Splitting |
| 2799 | 28.09.2011 | EMA's Current Positions on Transfer of a Marketing Authorisation |
| 2795 | 28.09.2011 | FDA's Current Position about Melamine Contamination in Pharmaceutical Excipients |
| 2750 | 28.09.2011 | EMA Reflection Paper on risk based Quality Management in Clinical Trials |
| 2790 | 21.09.2011 | EMA publishes two advisory Documents addressing a Number of Questions about centralised Admission Procedures |
| 2716 | 21.09.2011 | ICH Q4B - Annex 7(R2) on "Dissolution Testing" becomes binding in the USA too |
| 2409 | 21.09.2011 | FDA criticises SOP Training in pharmaceutical Companies |
| 2784 | 14.09.2011 | New: Revised USP Monographs of Spectroscopic Methods |
| 2774 | 14.09.2011 | EDQM gives Clarification concerning Stability Data for APIs within the Certification Procedure |
| 2712 | 14.09.2011 | Expiry Dating for Reagents and Solutions in Laboratories: What are FDA's Expectations? |
| 2761 | 09.09.2011 | Faster Sterility Tests for Biological Products |
| 2760 | 09.09.2011 | Rapid Methods - Influence of FDA's Strategic Plan for advancing Regulatory Science |
| 2771 | 07.09.2011 | Revision of USP 231 "Test for metal Catalysts" - what will change? |
| 2767 | 07.09.2011 | German Initiative 2D Matrix Code SecurPharm started on 31 August! |
| 2764 | 07.09.2011 | European QP Association forms Expert Panels |
| 2756 | 07.09.2011 | EMA Reflection paper on IVR/IWR systems |
| 2714 | 07.09.2011 | USP and FDA strengthen Collaboration |
| 2741 | 31.08.2011 | FDA withdraws Guideline on Validation of LAL Test |
| 2731 | 31.08.2011 | Report on the joint Good Clinical Practice (GCP) Inspection Pilot Programme |
| 2728 | 31.08.2011 | FDA Courses and Tests now available online |
| 2723 | 31.08.2011 | Result of EDQM Expert Meeting on Manufacture of WFI by Membrane Process |
| 2748 | 24.08.2011 | EU GMP Guide: New Requirements added for Batch Certification |
| 2730 | 24.08.2011 | FDA publishes Draft Guidance on the Documentation (510 k) of Medical Device Modifications |
| 2708 | 24.08.2011 | Official Tips for preparing an initial Drug GMP Inspection |
| 2698 | 24.08.2011 | New WHO guidance for Storage and Transportation |
| 2735 | 17.08.2011 | Final Report on the International API Inspection Programme published |
| 2734 | 17.08.2011 | EMA Guideline on bioanalytical Method Validation adopted |
| 2720 | 17.08.2011 | EMA Position Statement on Creutzfeldt-Jakob Disease and advanced Therapy medicinal Products |
| 2688 | 17.08.2011 | EMA: New Guideline on Development of Medicines for Paediatric Use |
| 2633 | 17.08.2011 | ECA Foundation Board Annual Meeting Report |
| 2719 | 10.08.2011 | Urgent Revision of EP 5.2.8. Minimising the Risk of Transmission of animal Spongiform Encephalopathy |
| 2702 | 10.08.2011 | Revised EU Guideline on Good Distribution Practice with major Changes |
| 2701 | 10.08.2011 | ECA Analytical Quality Control Working Group - OOS SOP Development |
| 2696 | 10.08.2011 | EU Product Quality Review now also part of WHO GMP main Principles |
| 2680 | 10.08.2011 | New WHO Document on Transfer of Processes with detailed Guidelines for Analytical Method Transfer |
| 2654 | 10.08.2011 | ECDC - Technical Report on the Prevention of Creutzfeldt–Jakob (vCJD) published |
| 2652 | 10.08.2011 | New PIC/S Q&A Document regarding Distribution Activities for APIs |
| 2629 | 10.08.2011 | FDA publishes SOP for "Notice to Industry" Letters for the Medical Devices Industry |
| 2667 | 08.08.2011 | WHO in charge of Qualifying QC Laboratories for the UN |
| 2659 | 08.08.2011 | WHO Technical Report incuding Annex 2 "Good Practices for pharmaceutical microbiological Laboratories" |
| 2658 | 08.08.2011 | FDA proposes Changes in Sterility Testing of Biological Products |
| 2710 | 03.08.2011 | New EMA Draft Guideline on Stability Data regarding Applications for Variations to a Marketing Authorisation |
| 2694 | 03.08.2011 | EMA publishes Compilation of Community Procedures on Inspections and Exchange of Information |
| 2686 | 03.08.2011 | New FDA Draft Guidance regarding Design Development of Medical Devices |
| 2682 | 27.07.2011 | Warning of Potential Contamination with Toxic Plasticizer |
| 2677 | 27.07.2011 | MPA Proposal: No GMP Certificate in Case of Violation of environmental Constraints |
| 2653 | 27.07.2011 | New FDA Guidance on Dosage Delivery Devices (measuring Spoons, Droppers, etc.) |
| 2641 | 27.07.2011 | Which kind of GMP Documentation is needed for an API Manufacturer who performs Sterilisation of an active Substance |
| 2617 | 27.07.2011 | FDA publishes Analysis of 2010 Warning Letter Statistics regarding Medical Devices |
| 2690 | 20.07.2011 | EU Commission publishes important new Draft Guideline on Good Distribution Practice of Medicinal Products for Human Use |
| 2683 | 20.07.2011 | New: ICH Guideline for ICH Q8, Q9 and Q10 implementation |
| 2669 | 20.07.2011 | WHO publishes Notice of Concern regarding GMP Deviations about two Manufactures located in India |
| 2666 | 20.07.2011 | Quality by Design for Generics - Case Studies |
| 2674 | 13.07.2011 | Excipact™ - the Certification Scheme for Pharmaceutical Excipients |
| 2664 | 13.07.2011 | Revision of the General Chapter NIR in PHARMEUROPA |
| 2656 | 13.07.2011 | The Falsified Medicines Directive published in the Official Journal of the European Union |
| 2643 | 13.07.2011 | FDA publishes Draft Guidance on Classification of Products as Drugs or Devices |
| 2649 | 06.07.2011 | New Guideline on EMA Certificates of Medicinal Products |
| 2638 | 06.07.2011 | FDA publishes Draft Guidance for Industry on Processing/Reprocessing Medical Devices |
| 2622 | 06.07.2011 | Contract Manufacturers and Contract Laboratories do no longer need to be pre-approved by DMA |
| 2620 | 06.07.2011 | FDA's membership of PIC/S - why it is important |
| 2644 | 29.06.2011 | FDA plans on publishing further GMP and CMC Guidances for Combination Products |
| 2637 | 29.06.2011 | Pfizer transfers first QbD Dossier within the FDA/EMA Project |
| 2635 | 29.06.2011 | FDA announces New Worldwide Strategy on GMP Supervision and Importation |
| 2613 | 29.06.2011 | Audio Presentation of ICH Q8, Q9 and Q10 now available |
| 2619 | 21.06.2011 | New ICH Q11 Guideline published |
| 2600 | 21.06.2011 | Why did FDA change their Guideline on Process Validation? |
| 2611 | 16.06.2011 | FDA creates "Super Office" for better GMP Monitoring and Fight against Counterfeit Medicines |
| 2604 | 16.06.2011 | New EMA Concept Paper on Process Validation of Biotechnology derived active Substances |
| 2595 | 08.06.2011 | How compliant is your supplier? FDA establishes new Online Inspection Database |
| 2587 | 08.06.2011 | Modernisation of USP Monographs |
| 2591 | 01.06.2011 | In Vitro Test Methods for Detection and Quantification of Botulinum Neurotoxins and Detection of Non-Endotoxin Pyrogens |
| 2588 | 01.06.2011 | The Council of the European Union adopts Falsified Medicines Directive! Major challenges for Users and Producers of APIs and pharmaceutical Excipients to be expected |
| 2578 | 01.06.2011 | EMA Report on Clinical Trials outside the EU |
| 2584 | 25.05.2011 | The 4th European GMP Conference a great Success - Read more about major GMP Developments |
| 2582 | 25.05.2011 | FDA publishes annual Fatalities Report regarding Blood Collection and Transfusion |
| 2581 | 25.05.2011 | The Challenges of Ensuring Laboratory Data Integrity |
| 2575 | 18.05.2011 | Suspension and Withdrawal of CEPs by EDQM |
| 2573 | 18.05.2011 | New Annex 14: Consequences for QPs |
| 2570 | 18.05.2011 | FDA asks how to improve existing Regulations |
| 2568 | 11.05.2011 | EMA: Monitoring of Products originating from Japan for the Possibility of Radioactivity |
| 2567 | 11.05.2011 | Quality by Design for pharmaceutical Excipients - IPEC publishes new Checklists and Q&A Document |
| 2558 | 11.05.2011 | EP 2.6.31. Microbiological Examination of herbal medicinal Products for oral Use under Revision |
| 2556 | 11.05.2011 | FDA's Strategic Priorities 2011 - 2015 now available |
| 2545 | 11.05.2011 | EMA's answers to FAQ on Computerised Systems |
| 2551 | 04.05.2011 | New PIC/S Document on GMP for APIs |
| 2405 | 04.05.2011 | CAPA among the most frequent GMP Deviations cited in FDA Warning Letters |
| 2548 | 28.04.2011 | Nuclear Load of pharmaceutical Products from Japan |
| 2539 | 28.04.2011 | Revision of Chapter 8 of the EC guide to GMP |
| 2499 | 28.04.2011 | EDQM's Enquiry on the new Draft of a general Chapter on Uniformity of Dosage Units |
| 2541 | 20.04.2011 | Risk Management Principles used for WHO Inspections of API facilities |
| 2534 | 20.04.2011 | EDQM requires more Information on the Manufacturer's Localisation (DUNS/GPS) for CEPs |
| 2522 | 20.04.2011 | New Guidance on Investigational Medicinal Products (IMPs) and Non Investigational Medicinal products (NIMPs) |
| 2516 | 20.04.2011 | Note for Guidance on minimising the Risk of transmitting Animal Spongiform Encephalopathy Agents via human and veterinary Medicinal Products |
| 2537 | 13.04.2011 | New Limit regarding unspecified Impurities for certain Substances - EDQM Updates respective CEPs |
| 2519 | 13.04.2011 | New answers published about Variations: EMA's updated "Post-Authorisation" Guideline |
| 2505 | 13.04.2011 | Quality IWG Training Material on ICH Q8, Q9 and Q10 |
| 2525 | 06.04.2011 | May unvalidated Methods also be accepted to test Drug Products? - The FDA answers |
| 2512 | 06.04.2011 | New EMA Checklist should help Type IA Variation Submissions |
| 2503 | 06.04.2011 | EMA and FDA announce Pilot Program for Assessment of QbD Applications |
| 2410 | 06.04.2011 | Annual Product Review (APR) as GMP Deviation in FDA Warning Letters |
| 2520 | 30.03.2011 | Video Presentation from FDA´s Dr Moheb Nasr available |
| 2514 | 30.03.2011 | Dedicated Facilities: FDA publishes Draft Guideline |
| 2502 | 30.03.2011 | News IPEC-Americas "Distributors Audit Guide" for Pharmaceutical Excipients |
| 2492 | 30.03.2011 | New Compilation of Community Procedures on Inspections and Exchange of Information |
| 2404 | 30.03.2011 | Production of WFI through Membrane Processes: Survey Results |
| 2486 | 25.03.2011 | Results of Survey on EU GMP Guide Revisions of Chapter 5 (Production) and 7 (Contract Manufacture and Analysis) |
| 2482 | 25.03.2011 | FDA Warning Letter Statistics 2010 regarding Process Validation and Qualification |
| 2444 | 25.03.2011 | Requirements on Validation of Sterilisation Procedures according to ISO 17665-1 |
| 2432 | 25.03.2011 | Surveillance of Medicinal Products- Annual Report of the German Federal States |
| 2490 | 16.03.2011 | China's new GMP Regulation effective since March 1, 2011 |
| 2469 | 16.03.2011 | Amended Directive 2001/83/EC includes stronger Guidance on GMP for APIs and Excipients |
| 2457 | 16.03.2011 | FDA: Applications to contain Information described by ICH Q8 |
| 2416 | 16.03.2011 | EMA plans on focusing more on API Manufacturers located in Asia |
| 2411 | 16.03.2011 | FDA focuses more on Supplier Qualification |
| 2460 | 09.03.2011 | New FDA Guidance Documents in Calendar Year 2011 |
| 2450 | 09.03.2011 | Evaluation of the Warning Letters issued by the FDA for the Fiscal Year 2010 with regard to Risk Management |
| 2438 | 09.03.2011 | Quality Agreement templates for every Participant of the 4th European GMP-Conference |
| 2434 | 09.03.2011 | FDA and EMA Pilot Program for joint Review of QbD Components of new Drug Marketing Applications |
| 2415 | 09.03.2011 | EMA plans extensive Revision of the EU GMP Guide |
| 2465 | 03.03.2011 | Inspection of API manufacturers: First Results of the WHO Pre-Qualification Programme |
| 2454 | 03.03.2011 | "Impurities: Guideline for Residual Solvents Q3C(R5)" has been finalised |
| 2451 | 03.03.2011 | Aide memoire of German Inspectors now also available in English |
| 2437 | 03.03.2011 | Validation on Rank 3 in the FDA Warning Letter Statistic 2010 regarding Medical Devices |
| 2407 | 03.03.2011 | Batch Record Review as GMP Deviation cited in FDA Warning Letters |
| 2467 | 01.03.2011 | EMA adjusts Fees for Marketing Authorisation Applications |
| 2452 | 01.03.2011 | ICH Q11 Draft Gelling On Lifecycle/Change Management and Control Strategy Components |
| 2426 | 01.03.2011 | Concept Paper on the Revision of the GCP Directive published |
| 2393 | 01.03.2011 | IMPD: EMA provides further Clarification for Quality of IMPs |
| 2371 | 01.03.2011 | Specific WHO Requirements for Dissolution Studies to Support Biowaivers |
| 2429 | 24.02.2011 | Revision or Renewal of CEPs: Requirements for Notifications to the EDQM |
| 2427 | 24.02.2011 | EU-GMP Guide: New Introduction with Clarification of Status of Part III |
| 2423 | 24.02.2011 | "Q3D: Impurities: Guideline for Metal Impurities" - a new ICH Concept Paper |
| 2355 | 24.02.2011 | Guideline on Testing for the Detection of Mycoplasma Contamination of veterinary medicinal Products |
| 2343 | 24.02.2011 | New EMA/HMPC Reflection Paper on Stability of Herbal Medicinal Products |
| 2327 | 24.02.2011 | DMA Document on Expectations for Audits of API Manufacturers |
| 2400 | 22.02.2011 | Updated Q&A Document on the Submission of Variations published |
| 2391 | 22.02.2011 | EDQM develops Live Demo for a Track & Trace System |
| 2386 | 22.02.2011 | EMA publishes final ‘Road map to 2015’ |
| 2373 | 22.02.2011 | New Pharmacovigilance Legislation adopted |
| 2354 | 22.02.2011 | Discussions about Material Certificates |
| 2341 | 22.02.2011 | EMA/HMPC Reflection Paper on Extracts Purification |
| 2323 | 22.02.2011 | USP <85>Bacterial Endotoxin Test - proposed interim Revision Announcement |
| 2401 | 17.02.2011 | In-depth analysis of the requirements on the new EU / PIC/S Site Master File |
| 2397 | 17.02.2011 | FDA takes action against non-compliant manufacturer |
| 2395 | 17.02.2011 | The number of Warning Letters issued to Drug Companies and API Manufacturers increases |
| 2356 | 17.02.2011 | FDA launches Basics for Industry Website |
| 2345 | 17.02.2011 | Quality of Herbal Medicinal Products - Current EMA/HMPC Q&A Document |
| 2330 | 17.02.2011 | Results of the Survey "Implementation of the new Annex 1 requirements for Capping" |
| 2439 | 16.02.2011 | New Pharma Directive on Counterfeit Medicine adopted by EU Parliament |
| 2420 | 10.02.2011 | New version of EudraGMP allows access to information from all Member States |
| 2418 | 10.02.2011 | EMA publishes ICH Q9 and ICH Q 10 as Part 3 of the EU GMP Guide |
| 2368 | 10.02.2011 | Growing Requirements on Process and Technology Transfers |
| 2359 | 10.02.2011 | EMA publishes two documents on the QP Declaration concerning GMP Compliance of the API |
| 2348 | 10.02.2011 | PIC/S SMF Guide Updated with Quality Management System Requirements |
| 2380 | 02.02.2011 | Detailed Analysis of FDA´s New Process Validation Guidance |
| 2369 | 02.02.2011 | Warning Letters Report 2010: Laboratory Controls and Analytical Methods again among Top Five GMP Deviations |
| 2363 | 02.02.2011 | Clean Room Classification: Draft on ISO 14644 published |
| 2346 | 02.02.2011 | News published about Guidance on Combating Counterfeit Drugs |
| 2384 | 27.01.2011 | FDA publishes Final of new Process Validation Guidance |
| 2381 | 27.01.2011 | The New GMP Annex 11 and Chapter 4 is Europe's Answer to Part 11 |
| 2331 | 27.01.2011 | Laboratory Control Issues Prominent in Recent Warning Letters to Four Overseas Firms |
| 2318 | 27.01.2011 | EDQM strengthens international Collaboration |
| 2361 | 19.01.2011 | New EU GMP Guide Chapter 4 on Documentation |
| 2352 | 19.01.2011 | New EU GMP Guide Annex 11 "Computerised Systems" |
| 2332 | 19.01.2011 | Compliance Policy Guide: RFID Studies and Pilot Programs for Drugs |
| 2314 | 19.01.2011 | ICH Q8, Q9 und Q10: new Q&A Document published |
| 2324 | 12.01.2011 | New FDA Guidance: Codevelopment of Investigational Drugs for Use in Combination |
| 2321 | 12.01.2011 | USP <1113> Microbial Identification - In Process Revision including a title change |
| 2310 | 12.01.2011 | New Best Practice Guides for the Submission and Processing of Variations published |
| 2308 | 12.01.2011 | FDA Inspections: Current Initiatives |
| 2322 | 05.01.2011 | Complete Revision of USP Chapter <1116> including updated Cleanroom Classification |
| 2316 | 05.01.2011 | FDA issues Guidance on Public Comment Procedures at Advisory Committee Meetings |
| 2313 | 22.12.2010 | Verification of Compendial Procedures - Changes Planned in the USP General Chapter <1226> |
| 2307 | 22.12.2010 | Pharmacopeial Forum (USP) going online and free |
| 2304 | 15.12.2010 | Revision of Chapter 6 of the EU GMP Guide Quality Control - New Concept Paper |
| 2302 | 15.12.2010 | What Information on Impurities is necessary for a Marketing Authorisation Application for a generic Medicinal Product in the US? |
| 2297 | 15.12.2010 | ICH Q7 How to do Guide - Video Presentation of APIC Conference available |
| 2290 | 08.12.2010 | EMA Concept Paper on Storage Conditions during Transport |
| 2285 | 08.12.2010 | New EMA Guideline on the Investigation of Bioequivalence |
| 2278 | 08.12.2010 | Frequently asked Question: How do I find all CEPs suspended by the EDQM? |
| 2273 | 08.12.2010 | Concept Paper: Quality Management Challenges in Pharmaceutical Industry |
| 2280 | 01.12.2010 | Will there soon be a shortage of QPs? |
| 2272 | 01.12.2010 | FDA publishes Report on Third Party Audits of Medical Device Manufacturers |
| 2267 | 01.12.2010 | Questions and Answers on the 'Guideline on the Limits of Genotoxic Impurities' |
| 2288 | 25.11.2010 | European Commission issues new Draft of Chapter 5 "Production" of the EU GMP Guide |
| 2277 | 25.11.2010 | FDA becomes official member of PIC/S |
| 2270 | 25.11.2010 | ISPE publishes new Baseline on the Subject of Risk Management |
| 2260 | 25.11.2010 | USP completes Evaluation of Recall of USP 33 |
| 2269 | 17.11.2010 | ECA establishes new Working Group - Invitation to get involved |
| 2265 | 17.11.2010 | "Outsourced Activities" - Revision of Chapter 7 of the EU GMP Guide |
| 2257 | 17.11.2010 | Important revision of ISO 14644-1: Clean Room Classification is likely to be changed |
| 2249 | 17.11.2010 | FIP Position Paper on Qualification of Paddle and Basket Dissolution Apparatus |
| 2254 | 10.11.2010 | GMP Problems cause the Suspension and Withdrawal of further CEPs |
| 2247 | 10.11.2010 | New FDA Guidance on the Development of Transdermal Systems |
| 2241 | 08.11.2010 | PDA published Technical Report No. 50, Alternative Methods for Mycoplasma Testing |
| 2253 | 03.11.2010 | FDA, EMA and TGA Inspection Programme with impressing Result |
| 2244 | 03.11.2010 | FDA drafts Guidance on the Qualification Process for Drug Development Tools |
| 2238 | 03.11.2010 | EMA Discussion Paper on intravenous Products with poorly resolvable APIs |
| 2232 | 28.10.2010 | WHO starts Pilot Programme for pre-qualifying APIs |
| 2230 | 28.10.2010 | FDA provides Tips for Inspections |
| 2226 | 28.10.2010 | FDA: New Guidance on Investigational New Drug Applications (INDs) |
| 2220 | 20.10.2010 | EMA Management Board adopts new Policies |
| 2213 | 20.10.2010 | FDA Inspection Reports: What is what? |
| 2222 | 13.10.2010 | GMP and Quality Regulation in Japan |
| 2217 | 13.10.2010 | The APIC revises the "ICH Q 7 How to do" Document |
| 2211 | 13.10.2010 | Clinical Trials: FDA publishes final Rules for Safety Reporting |
| 2209 | 06.10.2010 | New Biological Applications (BLA) - The Future of Pharmaceuticals |
| 2207 | 06.10.2010 | Variations Regulation: how to classify special Changes |
| 2206 | 06.10.2010 | Will FDA join PIC/S this Year? |
| 2203 | 29.09.2010 | ICH Q10: What European Inspectorates will look for |
| 2201 | 29.09.2010 | Non-Investigational Medicinal Products in CTAs: Results published of Public Consultation |
| 2200 | 23.09.2010 | Rx-360 receives Approval from FTC and exhibits at CPhI Tradeshow |
| 2194 | 23.09.2010 | MHRA requires active Maintainance of API Manufacturing Sites |
| 2185 | 23.09.2010 | WHO Publishes Guidelines on the Use of Quality Risk Management |
| 2183 | 23.09.2010 | Outcome of EMA Workshop on Clinical Trials and Global Medicines Development |
| 2167 | 15.09.2010 | English Supervisory Authority MHRA Publishes Answers to FAQs on Risk Management |
| 2161 | 15.09.2010 | EMA Reflection Paper on the Use of Electronic Data in Clinical Trials published |
| 2152 | 15.09.2010 | The New GAMP Good Practice Guide: How to Operate Computerised Systems in a GMP-Compliant Way |
| 2082 | 15.09.2010 | Clinical Trials in India - Current Developments |
| 2179 | 08.09.2010 | Important change to the planned production of EudraCT Version 8.0 and the Clinical Trials Application Form |
| 2177 | 08.09.2010 | WHO proposes new Sections for Guideline on Quality Assurance Topics |
| 2163 | 08.09.2010 | Revision of USP <1235> Vaccines for Human Use - General Considerations |
| 2137 | 08.09.2010 | FDA Fosters the Development of Better Medical Devices |
| 2174 | 01.09.2010 | FDA revises Guidance Document on Pre-Approval Inspections |
| 2156 | 01.09.2010 | New WHO Draft on the Manufacture of Sterile Medicinal Products |
| 2154 | 01.09.2010 | New Toxicological Data on Isopropylbenzene Trigger its Categorisation as Class 2 Solvent |
| 2125 | 01.09.2010 | Inspection of Biological Drug Products |
| 2159 | 25.08.2010 | FDA publishes Q&As on Drug Recalls |
| 2157 | 25.08.2010 | EMA and US FDA seek potential Candidates for joint GMP Inspection Programme |
| 2151 | 25.08.2010 | Impurities and Setting Specifications - the EMA Publishes Harmonised Policies on Its Q&A Page |
| 2145 | 18.08.2010 | Specific Requirements on Plastic Packaging Materials for APIs and Solid Dosage Forms? |
| 2142 | 18.08.2010 | EudraCT Version 8.0 and new CTA Application Form will go into production soon |
| 2120 | 18.08.2010 | What Is Wrong with APIs from China and India? |
| 2099 | 18.08.2010 | Free Access to WHO GMP Inspection Reports |
| 2147 | 12.08.2010 | Shared Audit at Pfizer's Manufacturing Site in the US |
| 2132 | 12.08.2010 | European Commission Will Revise IVD Guideline |
| 2130 | 12.08.2010 | Stability of Pharmaceutical Bulk Products - Which Data Are Dossier-Relevant? |
| 2114 | 12.08.2010 | Changes in the Pharmacopoeia: how to submit a Variation? |
| 2097 | 12.08.2010 | WHO revises Good Distribution Practices for Pharmaceutical Products |
| 2138 | 04.08.2010 | FDA includes Remanufacturers of Medical Single-Use Devices in cGMP Rules |
| 2133 | 04.08.2010 | MHRA publishes new Enforcement Strategy |
| 2123 | 04.08.2010 | New draft of ISO 14644-9 - Classification of Surface Cleanlinesss |
| 2126 | 28.07.2010 | How to Facilitate the Transition between Process Validation and Continuous Verification |
| 2111 | 28.07.2010 | FDA Proposes to Publish More Information about Inspection Planning and Outcomes |
| 2101 | 28.07.2010 | WHO publishes new Guideline for the preparation of a CRO Master File |
| 2109 | 20.07.2010 | FDA Videos on Quality by Design Initiatives |
| 2108 | 20.07.2010 | WHO Adopts GMP for APIs from the ICH Q7 Guideline - additional explanations added |
| 2104 | 20.07.2010 | FDA publishes Draft Guidance on CMC Postapproval Changes (Annual Reports) |
| 2121 | 14.07.2010 | New Questions in the RMM Discussion Forum |
| 2119 | 14.07.2010 | FDA Plans New Part 11 Inspections |
| 2117 | 14.07.2010 | Revision of EP chapter 5.1.6. Alternative Methods for Control of Microbiological Quality |
| 2089 | 14.07.2010 | WHO Publishes Guide on the Handling of Highly-Active Substances |
| 2085 | 14.07.2010 | Guidance for the use of UK Stand Alone Contract Laboratories published |
| 2077 | 14.07.2010 | USP 1050 Viral Safety of Biotechnology Products Derived from Cell Lines of Human or Animal Origin - proposed Revision |
| 2072 | 14.07.2010 | Authority Statement on Validation in Pharmaceutical Development |
| 2094 | 07.07.2010 | Revised Annex 13 on Investigational Medicinal Products (IMP) coming into operation |
| 2091 | 07.07.2010 | Part 2 EU GMP Guide on APIs Will No Longer Be Identical to ICH Q7 |
| 2074 | 07.07.2010 | The New Role of PAT as an Integral Part of QbD |
| 2067 | 07.07.2010 | EMA Draft Guideline open for Comments: Guideline on Quality Aspects on the Isolation of Candidate Influenza Vaccine Viruses in Cell Culture |
| 2086 | 30.06.2010 | FDA Plans to Revise cGMP Guide Focussing on Outsourcing and Raw Materials |
| 2080 | 30.06.2010 | FDA Publishes Draft Guidance on Third-Party Audits of Medical Device Manufacturers |
| 2069 | 30.06.2010 | News on Turkey's Tracking & Tracing System |
| 2065 | 30.06.2010 | Clinical Trials: new Document for public Consultation |
| 2064 | 30.06.2010 | New Documents by CMD(h) on "Unforeseen Variations" |
| 2070 | 23.06.2010 | Comprehensive Study about Verification of GMP Compliance at API Manufacturers published by DMA |
| 2048 | 23.06.2010 | Clinical Trials: FDA proposes new Data Falsification Rule |
| 2057 | 16.06.2010 | European Commission Decides to Establish a European Database for Medical Devices (Eudamed) |
| 2056 | 16.06.2010 | FDA Guideline to Reduce the Risk of Transmission of CJD and vCJD by Blood and Blood Products |
| 2051 | 16.06.2010 | Regulation amending the REACH Annexes relevant for SDS (Safety Data Sheet) |
| 2045 | 16.06.2010 | Revised Q&A Document available in EudraLex Volume 10 - Clinical Trials |
| 2043 | 09.06.2010 | EMA publishes Reflection Paper on ethical and GCP Aspects of Clinical Trials conducted in third Countries |
| 2041 | 09.06.2010 | USP seeks Submission of Proposals for Monograph Modernization |
| 2038 | 02.06.2010 | New Best Practice Guides for the Submission and Processing of Variations published |
| 2034 | 02.06.2010 | Outcome of the survey to the new EU GMP-Guideline Chapter 1 |
| 2032 | 02.06.2010 | Discussion of the EU Pharma Package in the European Council of Ministers |
| 2028 | 27.05.2010 | New Template for Drug API Quality Agreements |
| 2027 | 27.05.2010 | FDA Inspections in China - Consequences from the Heparin Case |
| 2025 | 27.05.2010 | Warning Letter Analysis for Process Validation |
| 2018 | 19.05.2010 | Database "QPSHARE" for Planning Joint Audits Already Used Intensively |
| 2016 | 19.05.2010 | Why Are There More and More Serious GMP Deficiencies on the Basis of Inspections? |
| 2014 | 19.05.2010 | Revised EMA Paper Specifies Requirements on Preparation, Conduct and Follow-Up of Official Inspections |
| 2005 | 19.05.2010 | Webinar with FDA's John Murray on Software Validation in the Field of Medical Devices |
| 2011 | 12.05.2010 | FDA answers questions to ICH Q8, Q9, and Q10 |
| 2007 | 12.05.2010 | EFPIA Publishes Results of the Track & Trace Project |
| 1997 | 12.05.2010 | Assessment of the Functioning of the 'Clinical Trials Directive' 2001/20/EC |
| 2002 | 05.05.2010 | EDQM initiates survey about the production of Water for Injection (WFI) |
| 1995 | 05.05.2010 | Further CEPs suspended and withdrawn by EDQM |
| 1989 | 05.05.2010 | Shared Audits: How Can You Find Partners in Order to Share Audit Costs? |
| 1986 | 05.05.2010 | FDA Finalises Guidance on the Standardisation of the Numerical Identification for Medicinal Products |
| 1984 | 05.05.2010 | FAQs on the EMA-FDA GCP Initiative published |
| 1999 | 29.04.2010 | Public Consultation on Annex 2 started |
| 1977 | 29.04.2010 | New FDA - NIH Initiative on a Formulations Framework for paediatric Drugs |
| 1972 | 29.04.2010 | EMA publishes Draft Guideline on the Requirements for Quality Documentation Concerning Biological Investigational Medicinal Products in Clinical Trials |
| 1967 | 29.04.2010 | Tracking & Tracing: EU decides on Amendments to Guidelines |
| 1951 | 29.04.2010 | EMA revises its Process Validation Guidelines |
| 1982 | 21.04.2010 | New EMA Guidelines in Force for GMP Infringements by Manufacturers of Active Ingredients and CEP Revocation |
| 1975 | 21.04.2010 | Will there soon be obligatory GMP Regulations for Excipients? |
| 1938 | 21.04.2010 | Germany's Preparations for the Traceability of Medicines |
| 1926 | 21.04.2010 | New EU Requirements in the Validation Process in the Form of a Revision of Section 1 of the EC GMP Guidelines? |
| 1979 | 14.04.2010 | Survey: Revision of Chapter 1 of the EU GMP Guide |
| 1969 | 14.04.2010 | European Compliance Academy (ECA) established as Foundation |
| 1968 | 14.04.2010 | Counterfeit Medicines: EFPIA Position Paper on the European Commission's Draft |
| 1948 | 14.04.2010 | New EMA Report on the 2008 Sampling and Test Programme |
| 1945 | 14.04.2010 | FDA Guidance for Submission of Documentation in Applications for Parametric Release |
| 1962 | 08.04.2010 | Report of the Annual Advisory Board Meeting of the European Compliance Academy (ECA) |
| 1960 | 08.04.2010 | Interesting Pilot Project for safe Trade Routes introduced |
| 1942 | 08.04.2010 | Real Time Release Testing (Parametric Release) - EMA publishes new Guideline Draft open for Consultation |
| 1953 | 31.03.2010 | EMA Guideline for Stability Testing for Applications for Variations in revision |
| 1928 | 31.03.2010 | MHRA Consultation Procedure for Strengthening Secure Supply Chains |
| 1917 | 31.03.2010 | Deviations and CAPA most frequent observations in FDA inspections |
| 1875 | 31.03.2010 | Microbiological Control of Herbal Drugs |
| 1961 | 24.03.2010 | European QP Association Releases Database "QPSHARE" |
| 1950 | 24.03.2010 | Final Annex 13 on Investigational Medicinal Products Published |
| 1939 | 24.03.2010 | FDA publishes finalized Guidance for Characterization and Qualification of Cell Substrates and Other Biological Materials |
| 1919 | 24.03.2010 | Central Anti-Counterfeit Laboratories - a Strategy to fight against Counterfeit Medicines |
| 1944 | 17.03.2010 | HPLC in FDA Warning Letters 2009 |
| 1941 | 17.03.2010 | Q-and-A List by EMA on the Centralised Procedure Extended |
| 1932 | 17.03.2010 | Memorandum of Understanding (MoU) signed between PIC/S and Russia |
| 1925 | 17.03.2010 | Which Role Does the Rx-360 Consortium Play in the Fight against Counterfeit Medicines? |
| 1922 | 08.03.2010 | FDA Director of Pediatric International Program to speak at ECA Development Conference |
| 1907 | 08.03.2010 | EMA's Inspectors Working Group Publishes Work Plan 2010 |
| 1903 | 08.03.2010 | Recent Statement by FDA on Process Validation - 3-Batch Validation Obsolete? |
| 1885 | 08.03.2010 | Current FDA Procedures for Counterfeit Medicines |
| 1929 | 03.03.2010 | FDA to speak at ECA Development Conference on Quality by Design |
| 1915 | 03.03.2010 | FDA announces new Programme for a more efficient Inspection of Imports |
| 1892 | 03.03.2010 | EMA publishes "Draft Guideline on Validation of bioanalytical Methods" |
| 1876 | 03.03.2010 | Review of Supplement 6.8 European Pharmacopeia 6th Edition |
| 1905 | 24.02.2010 | European Medicines Agency develops European Network of Paediatric Research |
| 1891 | 24.02.2010 | Genotoxicity Research - New HMPC Guideline for Herbal Medicinal Products |
| 1854 | 24.02.2010 | Inspection Results of the MHRA Published |
| 1849 | 24.02.2010 | PQR and Management Review: Increasing Importance |
| 1908 | 17.02.2010 | Q&A Document on Variations Regulation published |
| 1896 | 17.02.2010 | European QP Association To Release the Database "QPSHARE" Soon |
| 1889 | 17.02.2010 | Warning Letters Report 2009 - Increasing number of Warning Letters |
| 1883 | 17.02.2010 | FDA Guidance on "Mechanical Calibration of Dissolution Apparatus" Passed |
| 1878 | 17.02.2010 | EDQM announces new System for Revision/Renewal of CEP Certificates |
| 1873 | 11.02.2010 | Recall of USP 33-NF 28! |
| 1866 | 11.02.2010 | EU Commission finally issues Guidance on new Variations Rules |
| 1856 | 11.02.2010 | Inspection Results on Investigational Medicinal Products Published |
| 1850 | 11.02.2010 | EMA Update on Dedicated Facilities |
| 1818 | 11.02.2010 | Overview of new and withdrawn FDA Guidances 2009 |
| 1864 | 03.02.2010 | EC Commission Publishes Draft on the Creation of a Site Master File |
| 1852 | 03.02.2010 | New CAPA Guidance Published |
| 1845 | 03.02.2010 | Current Status of the Counterfeit Directive in the EU Parliament |
| 1813 | 03.02.2010 | Recent Changes Concerning the USP Dissolution Performance Verification Test |
| 1861 | 27.01.2010 | PIC/S publishes Example of Methodology for the Implementation of Quality Risk Management (QRM) in pharmaceutical Industry |
| 1842 | 27.01.2010 | Draft for the Revision of EU GMP Guide Chapter 2 "Personnel" |
| 1838 | 27.01.2010 | European Commission Publishes Proposal for Part 3 to the EC GMP Guide |
| 1837 | 27.01.2010 | FDA Publishes Statement on the Frequency of Media Fills |
| 1822 | 27.01.2010 | Discussion about Safety Features/2D Datamatrix Code Continues |
| 1857 | 20.01.2010 | The APIC Publishes Templates for Quality Agreements |
| 1844 | 20.01.2010 | European Commission Publishes Proposal for Part 3 to the EC GMP Guide |
| 1835 | 20.01.2010 | EDQM Announces the Suspension of Further CEPs |
| 1840 | 13.01.2010 | Revision of EU GMP Guide Chapter 1 Published |
| 1825 | 13.01.2010 | When Will the New Variations Regulation Come into Operation? |
| 1823 | 13.01.2010 | Riboflavin Test for Cleaning Validation - Standardisation regarding Information Sheet of VDMA |
| 1816 | 13.01.2010 | Interpretation of the New Annex 1 to the EC GMP Guide by PIC/S |
| 1821 | 16.12.2009 | Important Changes at EMEA |
| 1810 | 16.12.2009 | New FDA Guidance on Residual Solvents |
| 1805 | 16.12.2009 | Interesting Addition to the Q&As on ICH Q8, Q9 and Q10 |
| 1804 | 09.12.2009 | Annexes to ICH Q4B Guideline Reach Next Step |
| 1803 | 09.12.2009 | FDA adapts ICH Q8 (R2) Pharmaceutical Development as Guidance for Industry |
| 1790 | 09.12.2009 | New FDA Guidance on Impurities in APIs for Generics |
| 1801 | 02.12.2009 | EMEA: New Application Form for Scientific Advice |
| 1788 | 02.12.2009 | New White Paper by USP |
| 1782 | 02.12.2009 | Risk Posed by Counterfeit Personal Protective Equipment |
| 1798 | 25.11.2009 | Modern Aspects of Equipment Qualification |
| 1793 | 25.11.2009 | EMEA Reflection Paper on the Extrapolation of Results from Clinical Studies published |
| 1785 | 18.11.2009 | New Report on EU/EMEA and FDA Collaboration published |
| 1784 | 18.11.2009 | EMEA publishes Concept Paper on the Revision of the Guidance on Radiopharmaceuticals based Monoclonal Antibodies |
| 1780 | 18.11.2009 | The New Variations System - what is the current situation? |
| 1754 | 11.11.2009 | Method Transfer - USP Plans New General Chapter |
| 1722 | 11.11.2009 | Three years of the EU Paediatric Regulation - what happened? |
| 1774 | 04.11.2009 | FDA and EU Commission inform about Collaboration on Inspections |
| 1770 | 04.11.2009 | Chapter 7 of EC GMP Guide to be revised |
| 1767 | 28.10.2009 | FDA publishes Guidance for Industry regarding Risk Evaluation and Mitigation |
| 1751 | 28.10.2009 | Deputy Director Europe/US FDA will speak at QP Forum |
| 1749 | 28.10.2009 | FDA published final Guidance on End-of-Phase 2A Meetings |
| 1744 | 28.10.2009 | Extension of the FDA Pilot Programme for Biotechnological Products |
| 1747 | 21.10.2009 | FDA Warning Letter: New Procedure established |
| 1742 | 21.10.2009 | Public Assessment of the Clinical Trials Directive |
| 1740 | 15.10.2009 | Medical Devices Warning Letter Report 2009 - CAPA Still First |
| 1737 | 15.10.2009 | ICH Q8 Pharmaceutical Development Completed |
| 1738 | 07.10.2009 | Webcasts for FDA Transparency Task Force to Public Meetings available |
| 1735 | 07.10.2009 | FDA Issues Draft on cGMP Regulations for "Combination Products" |
| 1730 | 07.10.2009 | USP Suggests additional Testing for Visible Particles in Parenterals |
| 1732 | 30.09.2009 | Sample Documents for Participants in the Seminar Validation of Analytical Test Procedures |
| 1728 | 30.09.2009 | Personal Liability of the Qualified Person and Possibilities for Insurance |
| 1721 | 23.09.2009 | Dutch Medicines Authority Takes Measures after CEP Suspension by EDQM |
| 1674 | 23.09.2009 | Pharmaceutical Aspects of Product Information - EMEA publishes Concept Paper on a Guideline Revision |
| 1652 | 23.09.2009 | Supplier Qualification more and more in the Focus of Authorities |
| 1719 | 16.09.2009 | Quality Agreements for Excipients - Indispensable for a Transparent Supply Chain |
| 1695 | 16.09.2009 | CBER: Vaccines, Blood and Biologics - Exception or alternative Procedures |
| 1680 | 16.09.2009 | EMEA publishes Guideline on Investigation of Medicinal Products in the Term and Preterm Neonate |
| 1657 | 16.09.2009 | USP <1235> Vaccines for human Use - general Considerations |
| 1698 | 09.09.2009 | New EMEA Q&As on ICH Q8, Q9 and Q10 |
| 1697 | 09.09.2009 | FDA prepared to act more aggressively |
| 1665 | 09.09.2009 | EMEA Draft Guideline on Quality, Non Clinical and Clincal Aspects of Live Recombinant Viral vectored Vaccines |
| 1707 | 02.09.2009 | EudraGMP 2.0 gives public access to information about GMP certificates |
| 1703 | 02.09.2009 | EFPIA Criticises Increasing Number of Inspections |
| 1692 | 02.09.2009 | Quality by Design (QbD) - Contribution by Excipients Manufacturers |
| 1677 | 02.09.2009 | FAQ: Which Test for Evaluation of Activity of chemical Disinfections are relevant for the Pharmaceutical Industry? |
| 1702 | 26.08.2009 | Joint GCP Initiative Launched by EMEA and FDA |
| 1656 | 26.08.2009 | ICH Q4B Annex 8 now in Step4 |
| 1654 | 26.08.2009 | FDA limits Timeframe for Responding to a 483 |
| 1690 | 19.08.2009 | New ICH Q4B Documents issued for Europe |
| 1686 | 19.08.2009 | Internet presentations regarding Cleaning Validation |
| 1666 | 19.08.2009 | FDA: cGMP expectations in Pharmaceutical Development |
| 1636 | 19.08.2009 | Update of the PIC/S Recommendation PI 007-4 Validation of Aseptic Processes |
| 1694 | 12.08.2009 | EMEA Database on GMP Inspections now publicly available (EudraGMP) |
| 1687 | 12.08.2009 | Revised Q&A Document available in EudraLex Volume 10 - Clinical Trials |
| 1662 | 12.08.2009 | ICH Topic E16 Genomic Biomarkers Related to Drug Response - Deadline for Comments in September 2009 |
| 1642 | 12.08.2009 | FDA Opens 3 Offices in Europe |
| 1676 | 05.08.2009 | The New FDA Guideline on Impurities in Generics |
| 1672 | 05.08.2009 | European Commission Publishes Comments on the Variations Guidelines |
| 1649 | 05.08.2009 | Danish Medicines Agency - Questions and Answers on GMP for APIs |
| 1647 | 05.08.2009 | FDA Publishes Guideline to Fight Counterfeit Medicines |
| 1668 | 29.07.2009 | API´s from Asia at Risk - Further CEP´s Suspended |
| 1637 | 29.07.2009 | FDA publishes "The Enforcement Story" Report |
| 1661 | 22.07.2009 | Official Measures to Protect against Low-Quality APIs and Investigational Medicinal Products Co-ordinated throughout Europe |
| 1659 | 22.07.2009 | New FDA Draft Guidance on Postmarketing Studies and Clinical Trials |
| 1639 | 22.07.2009 | Danish Medicines Agency launches Project on Monitoring of GMP Compliance of APIs |
| 1634 | 15.07.2009 | EDQM issues Guidelines for OMCL Network |
| 1622 | 15.07.2009 | Public Consultation on Draft Revision 3 of detailed Guidance for the Request for Authorisation of a Clinical Trial |
| 1627 | 08.07.2009 | FDA Publishes New Q-and-A on cGMP for Penicillin Drugs |
| 1619 | 08.07.2009 | FDA adopts Pharmaceutical Development Guidance |
| 1616 | 08.07.2009 | FDA, TGA and EDQM establish Confidentiality Agreements |
| 1629 | 01.07.2009 | Further CEPs from Chinese and Indian Manufacturers suspended or withdrawn |
| 1624 | 01.07.2009 | EMEA Draft Transparency Policy published for Consultation |
| 1603 | 01.07.2009 | QPs implemented in new Canadian GMP Regulations? |
| 1611 | 23.06.2009 | GMP for Excipients - New Decision of the EU Commission may lead to Misinterpretation |
| 1601 | 23.06.2009 | Series of QP related Q&As published |
| 1608 | 17.06.2009 | New Guidance for Coordination of GCP Inspections published |
| 1606 | 17.06.2009 | Quo vadis GMP? |
| 1592 | 17.06.2009 | EMEA: Guideline on Missing Data in Confirmatory Clinical Trials |
| 1597 | 10.06.2009 | FDA forms Transparency Task Force |
| 1573 | 10.06.2009 | Current Ph.Eur. Requirements on Pharmaceutical Water |
| 1551 | 10.06.2009 | New Guidance: Formal Meetings Between the FDA and Sponsors or Applicants |
| 1595 | 03.06.2009 | EMEA publishes Question/Answers on Endotoxin Testing and Sterility Testing |
| 1589 | 03.06.2009 | EMEA issues new Draft regarding NIRS |
| 1569 | 03.06.2009 | Commission Directive regarding Advanced Therapy Medicinal Products approved |
| 1587 | 27.05.2009 | University of Mannheim initiates Survey on Risks in the Supply Chain |
| 1584 | 27.05.2009 | Pharmaceutical Development: New Challenges through ICH Q8 Annex |
| 1578 | 27.05.2009 | FDA requests a 19 Percent Budget Raise |
| 1580 | 20.05.2009 | Overview of New and Withdrawn FDA Guidances |
| 1568 | 20.05.2009 | EMEA publishes new Draft of "Guideline on Plasma derived Medicinal Products" |
| 1576 | 14.05.2009 | EMEA Publishes Guideline on Replacement of Rabbit Pyrogen Testing |
| 1574 | 14.05.2009 | ICH Publishes Questions-and-Answers Document on Q8, Q9 and Q10 |
| 1565 | 07.05.2009 | Two Recent FDA Warning Letters to Chinese API Manufacturers Reveal Enormous Risks in the Procurement of Starting Materials |
| 1385 | 07.05.2009 | EMEA publishes new Q and As on PAT |
| 1559 | 29.04.2009 | EDQM suspends five CEPs after inspecting Chinese Manufacturer Sites |
| 1553 | 29.04.2009 | New EMEA Concept Paper on the Revision of the EU Guideline Good Distribution Practices (GDP) |
| 1557 | 22.04.2009 | EDQM Guideline on Suspension or Cancellation of a CEP |
| 1555 | 22.04.2009 | Updated Categories of Variations in the New Variations Regulation |
| 1531 | 22.04.2009 | Batch Record Review in the Focus of Inspection Authorities |
| 1546 | 08.04.2009 | Validation Findings in FDA Warning Letters 2008 |
| 1540 | 08.04.2009 | EMEA Plans on Revising EC GMP Guide to Implement ICH Q10 |
| 1523 | 08.04.2009 | Validation of USP Methods - Incorporation of ISO Terms! |
| 1543 | 01.04.2009 | FDA issues new Draft Guidance regarding "Genotoxic and Carcinogenic Impurities in Drug Substances and Products" |
| 1521 | 01.04.2009 | FDA Guideline on Drug Stability Studies of Animal Drugs |
| 1498 | 01.04.2009 | PIC/S publishes new Aide-Memoire on the Inspection of Manufacturers of Active Pharmaceutical Ingredients |
| 1536 | 25.03.2009 | Implementation of the Variations Regulation: 2 Public Consultation Papers published |
| 1533 | 25.03.2009 | ECA's 10th Annual Review (2008) |
| 1525 | 25.03.2009 | Out-of-Specification Results and Failure Investigations in current FDA Warning Letters |
| 1496 | 25.03.2009 | CDER Update - FDA Recalls |
| 1493 | 25.03.2009 | New PIC/S Guide for the Inspection of Packaging Processes and Facilities |
| 1535 | 18.03.2009 | GMP Guideline Manager with new web-based software - free of charge for ECA Members |
| 1508 | 18.03.2009 | ICH Publishes Contact Address for Submitting Questions on Q8, Q9 and Q10 |
| 1490 | 18.03.2009 | EMEA publishes Questions and Answers on the Quality of IMPs |
| 1374 | 18.03.2009 | European Recommendations on Dissolution Testing |
| 1527 | 11.03.2009 | New USP General Chapter on Residual Solvents - Implementation by the FDA? |
| 1513 | 11.03.2009 | Results of the Survey: "How Will You React to the New FDA Guidance on Process Validation?" |
| 1501 | 11.03.2009 | Annex to ICH Q8 Pharmaceutical Development reached Step 5 |
| 1465 | 11.03.2009 | FDA Guidance on Standardised Identification for Medicinal Products |
| 1506 | 10.03.2009 | Update of the PIC/S Recommendation on the Validation of Aseptic Processes |
| 1503 | 10.03.2009 | EMEA publishes Questions and answers on the preparation of applications for a PIP and/or waiver |
| 1486 | 10.03.2009 | EMEA publishes Strategy Paper on 'Acceptance of Clinical Trials conducted in third Countries' |
| 1411 | 10.03.2009 | New FDA Guidance for shared Manufacturing of Biologics |
| 1488 | 25.02.2009 | Guidelines concerning Paediatric Clinical Trials and EudraCT published |
| 1481 | 25.02.2009 | EMEA Publishes New Version of the Reflection Paper on QP Discretion |
| 1480 | 25.02.2009 | API Focused MHRA Inspections at Dosage Form Manufacturers |
| 1363 | 25.02.2009 | Medical Devices Warning Letters Report 2008 - CAPA 1st |
| 1485 | 18.02.2009 | FDA Globalization Act: Far-reaching Consequences for the Pharmaceutical Industry |
| 1476 | 18.02.2009 | Warning Letters Report 2008 - Frequent Deficiencies in Deviation Reviews |
| 1473 | 18.02.2009 | Compliance Problems through Acetonitrile Shortage? |
| 1471 | 18.02.2009 | Monoclonal Antibodies - Comments received on the Guidelines |
| 1445 | 11.02.2009 | Annex 8 of ICHQ4B in Step3 |
| 1435 | 11.02.2009 | Dissolution Test - New ICH-/EMEA-Document |
| 1463 | 04.02.2009 | WHO Guide regarding GMP-Training Requirements |
| 1461 | 04.02.2009 | Acceptance of Third-Party Audits - Will There Be an Accreditation? |
| 1441 | 04.02.2009 | List of new, withdrawn and revised FDA guidances published |
| 1393 | 04.02.2009 | Pediatric Drug Development: FDA Requirements |
| 1459 | 28.01.2009 | New FDA Guidelines for an Increased Safety of Medicinal Products and Foodstuffs |
| 1452 | 28.01.2009 | FDA Starts Secure Supply Chain Pilot Programme |
| 1426 | 28.01.2009 | Track and Trace - New EU Requirements on the Packaging of Medicinal Products |
| 1280 | 28.01.2009 | The New APIC Quick Guide for Procuring GMP-Compliant APIs |
| 1450 | 21.01.2009 | Which Changes Have to Be Made to the Validation Strategy Due to the New FDA Process Validation Guide? |
| 1429 | 21.01.2009 | Result of the Public Consultation on the Revision of the PIP Guideline Published |
| 1408 | 21.01.2009 | Pharmaceutical Development: EMEA QWP plans for 2009 |
| 1449 | 15.01.2009 | EU Commission and EFPIA Activities against Counterfeit Medicine |
| 1438 | 15.01.2009 | New ICH Q4B Annexes |
| 1427 | 15.01.2009 | European Variations Regulation Published |
| 1430 | 08.01.2009 | Annex to ICH Q8 Pharmaceutical Development reached Step 4 |
| 1417 | 08.01.2009 | FDA Opens Offices in China and Tightens Inspections Also in Europe |
| 1421 | 17.12.2008 | European Commission Publishes Package of Measures against Counterfeit Medicines |
| 1415 | 17.12.2008 | ISO 9001 - New Version Published |
| 1413 | 10.12.2008 | EMEA Plans Amended Guideline on Parametric Release |
| 1386 | 10.12.2008 | Center for Biologics Evaluation and Research (CBER) - FY 2007 Annual Report |
| 1367 | 10.12.2008 | Procedures and Guidances for GCP Inspections |
| 1410 | 03.12.2008 | Report of the Annual Advisory Board Meeting of the European Compliance Academy (ECA) |
| 1395 | 03.12.2008 | FDA reported Fatalities following Blood Collection and Transfusion |
| 1390 | 03.12.2008 | FDA Pushing Ahead with Quality by Design (QbD) Developments |
| 1402 | 26.11.2008 | FDA`s New Process Validation Guidance - A detailed analysis |
| 1397 | 26.11.2008 | Implementation of the Paediatric Regulation: new Commission Guideline |
| 1255 | 26.11.2008 | EMEA publishes Drafts regarding the ICH Topic Q4B |
| 1399 | 20.11.2008 | FDA Publishes New Question and Answer Section on cGMP Compliance |
| 1372 | 20.11.2008 | Revised Annex 7 to the EC GMP Guide: Manufacture of Herbal Medicinal Products |
| 1323 | 20.11.2008 | MHRA publishes Good Pharmacovigilance Practice Guide |
| 1382 | 12.11.2008 | New Questions and Answers published by EMEA |
| 1273 | 12.11.2008 | New FDA Approach for Feedback on Applications for a Marketing Authorisation (NDA/ ANDA) |
| 1341 | 05.11.2008 | Variations Regulation: ENVI Committee of European Parliament adopts Draft Report on Variations |
| 1320 | 05.11.2008 | News from the GCP Inspectors Working Group |
| 1259 | 05.11.2008 | EDQM optimises Evaluation Process of CEP Applications |
| 1380 | 29.10.2008 | Change of Consultation Period for the Revision of Annex 13 |
| 1269 | 29.10.2008 | FDA Expectations regarding Facilities for Sampling Packaging Materials |
| 1260 | 29.10.2008 | Further Documents regarding Paediatric Regulation published |
| 1365 | 22.10.2008 | Consequences of the new ICH Guideline Q 10 (Pharmaceutical Quality Systems) |
| 1362 | 22.10.2008 | FDA Changes Medical Devices CGMP Rules |
| 1354 | 22.10.2008 | WHO Recommendations on Anti-Counterfeit Technologies |
| 1360 | 15.10.2008 | New Annex 3 "Manufacture of Radiopharmaceuticals" Comes into Operation on 1 March 2009 |
| 1336 | 15.10.2008 | EMEA publishes Guideline on Training and Qualification of GMP Inspectors |
| 1361 | 08.10.2008 | FDA Changes CGMP Rules (21 CFR 210/211) |
| 1356 | 08.10.2008 | Counterfeit Drugs - Questions-and-Answers Paper from FDA |
| 1345 | 08.10.2008 | What Does a GMP-Compliant Certificate for Excipients Look Like? - New USP General Chapter <1080> |
| 1333 | 24.09.2008 | Several GCP Inspection Procedures published |
| 1288 | 24.09.2008 | REACH - Possible Consequences for Validation of Disinfectants |
| 1300 | 18.09.2008 | Guideline on Investigation of Bioequivalence released for Public Consultation |
| 1289 | 18.09.2008 | New FDA Plans possibly impact Supply Chain and related Import Activities |
| 1311 | 10.09.2008 | USP Chapter <645> 'Water Conductivity' Revised |
| 1281 | 10.09.2008 | FDA Submission Requirements on Parametric Release for End-Sterilised Products |
| 1316 | 04.09.2008 | Current Aspects of Cleaning Validation in the Literature |
| 1296 | 04.09.2008 | Stricter Requirements for the Transport of Medicinal Products at Room Temperature |
| 1309 | 27.08.2008 | EMEA Drafts Pilot Project for the Rationalisation of GMP Inspections |
| 1283 | 27.08.2008 | New Draft for FDA Globalisation Act Calls for Quality Risk Management Plans |
| 1294 | 20.08.2008 | Quality by Design for Biotechnological Products: New FDA Pilot Programme |
| 1267 | 20.08.2008 | EMEA Evaluates Use of GMP-Compliant API Production |
| 1284 | 13.08.2008 | Eustite - Inspector Trainig Courses started succsessfully |
| 1276 | 13.08.2008 | Impurities in Antibiotics: EMEA Issues New Concept Paper |
| 1249 | 06.08.2008 | Current Interpretation of the FDA Requirements on Sampling |
| 1248 | 06.08.2008 | EDQM publishes Update on Heparin Monograph and Policy Paper for dealing with potentially genotoxic Impurities |
| 1245 | 30.07.2008 | Joint Inspections and Further Cooperation between EMEA and FDA Announced |
| 1244 | 30.07.2008 | FDA Publishes New Guideline on the Manufacture of Phase 1 Investigational Medicinal Products |
| 1240 | 23.07.2008 | OECD: Biotechnology Update of the Internal Co-ordination Group of Biotechnology |
| 1239 | 23.07.2008 | The FDA Clinical Investigator Inspection List |
| 1234 | 16.07.2008 | EDQM publishes new Requirements for the CEP Certification Procedure |
| 1235 | 16.07.2008 | European Commission publishes new Variations Regulation Draft |
| 1231 | 09.07.2008 | U.S. Department requests higher Budget for FDA |
| 1230 | 09.07.2008 | EMEA Updates Inspection Manual with Reference to ICH Q9 |
| 1227 | 02.07.2008 | Draft Guideline on Safety and Efficacy Follow-Up-Risk Management of Advanced Therapy Medicinal Products |
| 1226 | 02.07.2008 | ICH Guideline Q10 "Pharmaceutical Quality System" Finalised |
| 1223 | 25.06.2008 | FDA publishes draft of Biological Product Deviation Reports Summary |
| 1222 | 25.06.2008 | Will the Quality by Design Approach Increase Costs and Resources? |
| 1219 | 18.06.2008 | Visions of CBER for Vaccine Manufacturing |
| 1218 | 18.06.2008 | New Amendments to Eudralex Volume 10 |
| 1214 | 11.06.2008 | European QP Association Initiates Shared Audit Database |
| 1213 | 11.06.2008 | Medicine Counterfeits: EU Commission publishes Comments from Associations |
| 1210 | 04.06.2008 | Consequences of the Guideline 98/8/EG and the Biocide Act for the pharmaceutical industry |
| 1209 | 04.06.2008 | European Commission, EMEA and FDA decide to intensify cooperation |
| 1206 | 29.05.2008 | Training Slides on Validation from the WHO |
| 1205 | 29.05.2008 | GHTF Publishes Auditing Guideline |
| 1202 | 21.05.2008 | EDQM publishes "Guide to the Preparation, Use and Quality Assurance of Blood Components" |
| 1201 | 21.05.2008 | New FDA Plans Intend to Ensure Drug Safety for Imported Products |
| 1197 | 14.05.2008 | Risk-based Inspection Programme - a Model for Future Inspections? |
| 1196 | 14.05.2008 | New Draft of Inspection Guideline on Tissue and Cell Procurement
|
| 1195 | 14.05.2008 | Revised Chapter 4 of the EU Guideline to GMP Released for Public Consultation |
| 1191 | 07.05.2008 | Adoption of the Commission Proposal on Variations (co-decision part) |
| 1190 | 07.05.2008 | PIC/S Publishes Guideline for GMP in Healthcare Establishments |
| 1189 | 07.05.2008 | Will the FDA Continue Its Initiative "cGMPs for the 21st Century"? |
| 1185 | 30.04.2008 | European Compliance Academy (ECA) Initiates New Working Group |
| 1184 | 30.04.2008 | EU Plans Extension of GMP Guide for APIs to Quality Risk Management |
| 1183 | 30.04.2008 | ICH Q11 - A New Guideline for the Development of APIs Is Being Created |
| 1179 | 23.04.2008 | Draft Annex 13 Released: European Commission Asks for Comments |
| 1178 | 23.04.2008 | EMEA Issues Statement on WFI Preparation through Reverse Osmosis |
| 1177 | 23.04.2008 | New FDA Guidance on Dissolution Testing: No Calibrator Tablets! |
| 1172 | 16.04.2008 | EMEA Publishes Q-and-As on Genotoxic Impurities |
| 1171 | 16.04.2008 | EU Publishes New Version of EU GMP Guide Annex 11 "Computerised Systems" |
| 1170 | 16.04.2008 | FDA Reacts to Recent Problem Cases and Establishes
GMP Inspection Office in China |
| 1167 | 09.04.2008 | FDA Withdraws Changes to the cGMP Guide (21 CFR 210/211) |
| 1166 | 09.04.2008 | Consultation on the Revised Annexes 1, 2 and 3
on the Clinical Trial Application Form |
| 1147 | 09.04.2008 | European Commission Plans Far-Reaching Changes to GMP and GDP in the Fight against Counterfeit Medicines |
| 1162 | 02.04.2008 | Chinese Regulatory Agency: Drug and API Importers are Responsible for Supply Quality |
| 1161 | 02.04.2008 | Deviations and Failure Investigation - CAPA in the Light of FDA Inspections |
| 1158 | 26.03.2008 | USP General Chapter <1058> Analytical Instrument Qualification Comes into Force on 1 August 2008 |
| 1156 | 26.03.2008 | FDA Confirms Use of "Container Closure System Integrity Testing" instead of "Sterility Testing" in Stability Testing |
| 1152 | 19.03.2008 | EMEA Releases Concept Paper on a Guideline on Documentation Concerning Biological IMPs |
| 1151 | 19.03.2008 | FDA Provides Certifications to Accompany Applications or Submissions on Website |
| 1146 | 19.03.2008 | New Version 10.0 of GMP Guideline Manager Software Released - Free of Charge for ECA Members |
| 1144 | 12.03.2008 | Annual Review 2007
|
| 1143 | 12.03.2008 | GMP for Excipients - The USP General Information Chapter <1078> under Revision |
| 1142 | 12.03.2008 | CDER Guidance Agenda Published |
| 1138 | 05.03.2008 | FDA Requests Nearly $2.4 Billion as Part of the President's Fiscal Year (FY) 2009 Budget |
| 1137 | 05.03.2008 | Handling of OOS Results – Still an Important Issue in FDA Inspections
|
| 1136 | 05.03.2008 | Warning Letters Report 2007
Frequent Deficiencies in Quality Control Labs and in the Clearing of Deviations in Production |
| 1135 | 04.03.2008 | 10th APIC Conference on Active Pharmaceutical Ingredients |
| 1131 | 28.02.2008 | FDA Approval for Parenteral Products in Plastic Immediate Containers |
| 1130 | 28.02.2008 | FDA Guidance on Alternative Sterility Testing |
| 1129 | 28.02.2008 | New EMEA Paper on Markers for Herbal Medicinal Products |
| 1126 | 21.02.2008 | EMEA Issues Statement on Status of Revision of GMP Guide Concerning "Dedicated Facilities" |
| 1125 | 21.02.2008 | EU Publishes Changes to Chapter 1 EC GMP Guide and Annex 20 |
| 1124 | 21.02.2008 | New Version of Annex 1 to the EC GMP Guide on Sterile Manufacture Published |
| 1119 | 13.02.2008 | List of New, Withdrawn and Revised FDA Guidances Published |
| 1118 | 13.02.2008 | EMEA's Piotr Krauze Confirmed to speak at ECA Good Development Conference |
| 1117 | 13.02.2008 | Eudralex Volume 10 Updated |
| 1113 | 06.02.2008 | Outcome of the Public Consultation of the Review of the Variations Regulations (Comitology Part) Published |
| 1112 | 06.02.2008 | Expert Team of German Medicines Manufacturers' Association Develops Quality System Manual |
| 1111 | 06.02.2008 | EU Council Adopts EFPIA Joint Technology Initiative on Innovative Medicines |
| 1108 | 30.01.2008 | FDA Foreign Inspection Programme under Review |
| 1107 | 30.01.2008 | Medical Devices Warning Letters Report 2007 - Process Validation Again among the Top 5 |
| 1104 | 24.01.2008 | European QP Association Plans on Launching Interest Group for Advanced Therapies |
| 1103 | 24.01.2008 | FDA Reacts to Report Accusing the Authority of Serious Deficiencies |
| 1100 | 16.01.2008 | Amendment to Chapter 5 of the GMP Guide ("Qualification of Suppliers") Expected in Early 2008 |
| 1099 | 16.01.2008 | Recognition of Compendial Methods -
EMEA Publishes New ICH Q4B Documents |
| 1096 | 19.12.2007 | Identification and Classification of Deficiencies in Glass Packaging Materials |
| 1095 | 19.12.2007 | New GMP-Guide on Qualification Approved by the ASTM |
| 1091 | 13.12.2007 | ICH Publishes Annex to ICH Q8 |
| 1090 | 13.12.2007 | FDA Modifies cGMP Guide - New Text Published |
| 1087 | 05.12.2007 | FDA Inspections at Biological Drugs Sites |
| 1086 | 05.12.2007 | The FDA Does Recognise Alternative Compendia (BP/EP/JP) After All |
| 1083 | 28.11.2007 | Complaint Handling and Recalls in the Focus of Regulatory Inspections and Enforcement |
| 1082 | 28.11.2007 | New Proposals for Analytical Balances and Quality-Relevant Weighing Processes in the American Pharmacopoeia |
| 1079 | 21.11.2007 | Classification of GMP-Observations in the Various Inspectorates |
| 1078 | 21.11.2007 | EMEA Publishes Draft on Assessment of the Quality of Medicinal Products Containing Existing/Known Active Substances |
| 1074 | 15.11.2007 | European Companies and QPPVs in the Focus of U.K. Pharmacovigilance Inspections |
| 1073 | 15.11.2007 | Implementation of Modern GMP Aspects: Revision of the Annex 2 of the EC GMP Guide as an Example |
| 1072 | 15.11.2007 | New EMEA Guideline Draft on Stability Testing with Modified Testing Conditions |
| 1069 | 07.11.2007 | FDA Estimates Effort for Implementing Requirements for Medical Devices |
| 1068 | 07.11.2007 | EU Commission Publishes Draft of New Variation Regulation |
| 1064 | 02.11.2007 | Input for ECA's RMM Best Practice Guide Chapter from Leading Industry Expert |
| 1063 | 02.11.2007 | EU Commission and EMEA Plan Extensive Further Development in the GMP Environment |
| 1060 | 25.10.2007 | Clinical Trials in India: recent developments |
| 1059 | 25.10.2007 | FDA Plans Changes to the cGMP Guide (21 CFR 211) |
| 1058 | 22.10.2007 | Swiss Biotech Association and IFAPP in co-operation with the ECA |
| 1057 | 22.10.2007 | New GAMP® Good Practice Guide "Electronic Data Archiving" |
| 1055 | 22.10.2007 | News from the FDA Regarding Inspections, GMP Deficiencies and Recalls |
| 1050 | 09.10.2007 | How to Overcome Problems during Validation of an Alternative Microbiological Test System? |
| 1049 | 09.10.2007 | European Commission Releases New GMP Guide Annex 2 for Biologics for Consultation |
| 1048 | 09.10.2007 | EMEA Publishes New HMPC Guideline on Combination Herbal Medicinal Products |
| 1044 | 04.10.2007 | India's Central Drug Authority Gets More Power to Control Clinical Trials |
| 1043 | 04.10.2007 | Outsourcing: What Has to Be Taken into Account from a GMP Perspective? |
| 1042 | 04.10.2007 | Update of USP General Chapter <1010> "Analytical Data - Interpretation and Treatment" Suggested |
| 1038 | 26.09.2007 | EMEA Publishes Updated Questions & Answers Guidance on Variations |
| 1037 | 26.09.2007 | USP Chapter <643> TOC and <645> Conductivity in Revision |
| 1036 | 26.09.2007 | UK Pharmaceutical Industry Association Revises Guidelines for Phase I Trials |
| 1032 | 19.09.2007 | FDA CDER Publishes Facts-and-Figures Document |
| 1031 | 19.09.2007 | FDA Publishes Guideline for Eligibility Determination for Donors of Human Cells and Tissues |
| 1030 | 19.09.2007 | PIC/S Publishes New Version of GMP Guide |
| 1027 | 12.09.2007 | Current EMEA Statements regarding the Introduction of the Harmonised Test Methods in Microbiology |
| 1026 | 12.09.2007 | Raman Spectroscopy in the USP |
| 1022 | 05.09.2007 | EDQM Issues Q&A Documents on Harmonised Microbiological Test Procedures |
| 1021 | 05.09.2007 | ISPE Publishes White Paper on "Dedicated Facilities" |
| 1017 | 29.08.2007 | Harmonisation of EMEA GMP/GDP and GCP Inspectors Groups |
| 1016 | 29.08.2007 | Revision of the EU Variations Regulations |
| 1012 | 22.08.2007 | EU GMP Guide Annex 6 "Manufacture of Medicinal Gases" Draft Revision published for Public Consultation |
| 1011 | 22.08.2007 | EMEA Publishes Guideline on Strategies to Identify and Mitigate Risks in first-in-human Clinical Trials with IMPs |
| 1007 | 16.08.2007 | EMEA Publishes Q&A Document on the ASMF Procedure and on Specifications of Residual Solvents |
| 1006 | 16.08.2007 | USP Publishes Revised General Chapter on NIR and Takes Account of the Increased Use of NIR in PAT |
| 1003 | 08.08.2007 | Free Webcast from the Chairman of the European QP Association Available |
| 1002 | 08.08.2007 | MicroSeq Chapter of ECA's RMM Good Practice Guide published for discussion |
| 1001 | 08.08.2007 | ISO Standard 15378 with GMP Requirements to Manufacturers of Primary Packaging Materials Adopted as EN Standard |
| 997 | 01.08.2007 | Free Webcast with Chairman of ECA's Working Group on
Rapid Microbiological Methods Dr Robert Johnson |
| 996 | 01.08.2007 | EMEA Provides Guidance for
Implementing Harmonised Microbiology Chapters |
| 995 | 01.08.2007 | USP General Chapter <1226> Comes into Force on 1 December 2007 |
| 992 | 26.07.2007 | Report of the Annual Advisory Board Meeting of the European Compliance Academy (ECA) |
| 991 | 26.07.2007 | MHRA Publishes Pharmacovigilance Inspection Metrics Reports for 2006 |
| 990 | 26.07.2007 | FDA's CBER Updates Q&A List Concerning the Current Good Tissue Practice (CGTP) Final Rule |
| 987 | 18.07.2007 | New Guidance Published in Eudralex Volume 10 - Clinical Trials |
| 986 | 18.07.2007 | FDA's Office CBER Publishes Q&As on Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) |
| 983 | 11.07.2007 | EMEA Holds Workshop on First-in-Man Clinical Trials Draft Guideline |
| 982 | 11.07.2007 | FDA Representatives Conduct Q&A Session on OOS Results |
| 979 | 04.07.2007 | Harmonisation of Pharmaceutical Water Requirements in Pharmacopoeias Continues |
| 978 | 04.07.2007 | FDA Announces Expansion of Cooperation with EC and EMEA |
| 975 | 28.06.2007 | EMEA Facilitates Proposal to Establish a Harmonised Format for IMP Batch Release Certification |
| 974 | 28.06.2007 | EMEA Issues SOP on Coordination of Pre-Approval GxP Inspections |
| 971 | 20.06.2007 | TOC in the Japanese Pharmacopoeia |
| 970 | 20.06.2007 | Changes to Chapter 5 of the EU GMP Guide Proposed |
| 967 | 13.06.2007 | FDA's CVM Publishes New Guidances on CMC |
| 966 | 13.06.2007 | GMP-Compliant Sanitisation of Pharmaceutical Water Systems |
| 962 | 06.06.2007 | Dr Robert Johnson Appointed Chairman of ECA RMM Working Group |
| 961 | 06.06.2007 | ICH Q10 Emphasises Quality Management Systems |
| 960 | 06.06.2007 | Proposed Change for Dissolution Performance Verification Testing |
| 957 | 31.05.2007 | ICH Publishes Q10 Guideline as Step 2 |
| 956 | 30.05.2007 | Richard Bonner Accepts Nomination as Director Regulatory Affairs for the European Compliance Academy (ECA)
|
| 955 | 30.05.2007 | Final FDA Computerized Systems Guideline available |
| 954 | 30.05.2007 | OECD Analyses Economic Effects of Counterfeiting and Piracy of Pharmaceuticals |
| 950 | 23.05.2007 | EMEA Analyses Quality Defects in Centrally Authorised Products |
| 949 | 23.05.2007 | Supplier Qualification in the Focus of EU GMP Inspectorates |
| 945 | 14.05.2007 | LIMS/CDS Get More Attention in Inspections |
| 944 | 14.05.2007 | EMEA Launches EudraGMP Database |
| 928 | 14.05.2007 | Justification of Limits for Cleaning Validation in the
Manufacture of Active Pharmaceutical Ingredients |
| 941 | 09.05.2007 | European Qualified Person Association
Presents Results of Members Survey |
| 940 | 09.05.2007 | FDA Withdraws Recognition of Alternative Pharmacopoeias (BP/EP/JP) |
| 939 | 09.05.2007 | USP Defines New Procedure for Reference Standards |
| 936 | 03.05.2007 | The Product Quality Review in the Focus of Inspections |
| 935 | 03.05.2007 | EMEA Reflection Paper on Handling Deviations |
| 932 | 25.04.2007 | USP Harmonises Requirements on Sterile Water |
| 927 | 19.04.2007 | EMEA and European Commission Publish Document to Describe the Issue and Update of GMP Certificates |
| 926 | 18.04.2007 | Annual Review 2006 |
| 925 | 17.04.2007 | Current GMP and Regulatory Developments on
Active Pharmaceutical Ingredients |
| 922 | 12.04.2007 | EMEA Publishes Set of Auditing Documents for Joint Audit Programme |
| 921 | 12.04.2007 | The UN International Narcotics Control Board Warns of Counterfeit Medicines |
| 918 | 03.04.2007 | Current FDA Activities |
| 917 | 03.04.2007 | European Commission Publishes Draft of GMP Directive on Certain Excipients |
| 914 | 28.03.2007 | Deviations and Failure Investigation - CAPA in the light of FDA Inspections |
| 913 | 28.03.2007 | UK MHRA Publishes Guidance for Qualified Persons |
| 910 | 21.03.2007 | FDA Director Steven Galson presents CDER update |
| 909 | 21.03.2007 | Inspection Deficiencies regarding Validation and Qualification Aspects in EMEA Inspections |
| 908 | 21.03.2007 | Multi User Version of the GMP Guideline Manager Software for Company Members |
| 905 | 14.03.2007 | New Version 9.0 of GMP Navigator Software Released under New Name |
| 903 | 14.03.2007 | Process Validation Again Among the Top Five
in the Warning Letters Report for Medical Devices |
| 904 | 14.03.2007 | ISPE Publishes New Guideline on Water and Steam Systems |
| 900 | 08.03.2007 | Pharmaceutical Engineering in the Focus of EMEA Inspections |
| 899 | 08.03.2007 | Biofilms as the Cause of OOS/OOT Results |
| 896 | 01.03.2007 | The Product Quality Review gets down to business |
| 895 | 01.03.2007 | New HMPC Guideline Published |
| 892 | 21.02.2007 | EMEA Publishes 2007 Work Plan for
Ad Hoc GMP Inspection Services Group |
| 891 | 21.02.2007 | EMEA Publishes Content of the
GMP Inspections Database for the First Time |
| 888 | 14.02.2007 | FDA Requests More Budget for Public Health Goals |
| 887 | 14.02.2007 | USP Statement on Dissolution Testing |
| 884 | 07.02.2007 | Global Efforts in Cold Chain Management and Good Transportation Practice Increase |
| 883 | 07.02.2007 | New Draft of Chapter 1 "Quality Management" of the EU GMP Guidelines Published |
| 879 | 31.01.2007 | FDA Requirements on Reporting and Interpreting OOS Results |
| 878 | 31.01.2007 | FDA 483s Available on the World Wide Web |
| 874 | 24.01.2007 | List of New, Withdrawn and Revised FDA Guidances Published |
| 873 | 24.01.2007 | EDQM Publishes TOP TEN Deficiencies Found in Applications for CEPs |
| 870 | 16.01.2007 | Validation Aspects in US FDA Warning Letters |
| 869 | 16.01.2007 | EMEA Publishes Concept Paper on Annex 11 - Computerised Systems |
| 865 | 10.01.2007 | New HMPC Guidelines for Herbal Medicinal Products |
| 864 | 10.01.2007 | Warning Letters Report 2006 |
| 861 | 19.12.2006 | ECA Working Group on Rapid Microbiological Methods (RMM) Offers Membership |
| 860 | 19.12.2006 | FDA Advisory Committee discusses new Quality Guidances and Initiatives |
| 857 | 13.12.2006 | European QP Association's first QP Forum a Complete Success |
| 856 | 13.12.2006 | Postponed Implementation of USP Microbiology Chapters |
| 855 | 11.12.2006 | FDA Criticises Maintenance and Cleaning of Equipment |
| 852 | 07.12.2006 | Active Substance Master File Guideline in Revision |
| 851 | 07.12.2006 | Publicly accessible Webinar on FDA Study Results |
| 847 | 30.11.2006 | Comprehensive FDA Study on Inspections and GMP Deviations Published |
| 846 | 30.11.2006 | EMEA Publishes New Q&A Document on Its Website |
| 843 | 21.11.2006 | APIC Revises Third-Party Auditing Programme for APIs |
| 842 | 21.11.2006 | Delegation of GMP-Inspections within the EU |
| 838 | 16.11.2006 | ICH collaborates with Standards Development Organisations to enforce globalisation of its standards |
| 837 | 16.11.2006 | Readability of Label and Package Leaflet - Revised Draft of the European Commission |
| 833 | 09.11.2006 | FDA Defines the "Term Quality Unit" |
| 832 | 08.11.2006 | Significance of USP General Chapters above <999> for FDA |
| 828 | 31.10.2006 | Analysis of GMP Inspections by MHRA |
| 829 | 31.10.2006 | ICH Q9 - Training Material Published |
| 824 | 24.10.2006 | Draft General Chapter USP <1226> Verification of Compendial Methods Completely Revised |
| 823 | 24.10.2006 | Eudralex Volume 10 Summarises Requirements on Clinical Trials |
| 822 | 23.10.2006 | New USP Draft for General Chapter <621> Chromatography with Impact on HPLC System Suitability Tests |
| 818 | 17.10.2006 | HPLC in FDA Warning Letter |
| 817 | 17.10.2006 | New ICH Guideline Q4B |
| 816 | 17.10.2006 | New FDA Activities for Minimising the TSE Risk |
| 812 | 12.10.2006 | New OOS Guidance by FDA! |
| 810 | 11.10.2006 | Validation - a New Philosophy Ahead |
| 808 | 05.10.2006 | FDA Publishes Final Guidance: Quality System Approach to Pharmaceutical cGMP Regulations |
| 806 | 04.10.2006 | New European QP Association Counts more than 350 Members already |
| 804 | 02.10.2006 | EMEA Aims at Harmonising the Requirements on Biotechnological Medicinal Products in Clinical Trials |
| 805 | 02.10.2006 | EMEA Develops GMP Database |
| 801 | 26.09.2006 | FDA Publishes Guidance Agenda for the Coming Fiscal Year 2007 |
| 800 | 26.09.2006 | Initiative by Members of EU Parliament Calls for GMP Inspections of API Manufacturing Sites within and outside the EU |
| 797 | 20.09.2006 | New EMEA Guideline on Declaration of Herbal Medicinal Products |
| 796 | 20.09.2006 | How to Comment FDA Proposed Regulations |
| 795 | 20.09.2006 | EMEA plans Guideline on Quality of Combination Herbal Medicinal Products |
| 789 | 07.09.2006 | Product Quality Review - Consequences from the EC GMP Guideline and Authority Expectations |
| 788 | 07.09.2006 | EMEA supports PAT for Variations |
| 787 | 07.09.2006 | New USP Chapter for the Pharmaceutical Microbiology |
| 783 | 30.08.2006 | GMP Webinars Now Available as Recorded Webinars |
| 782 | 30.08.2006 | EMEA Revises Compilation of Community Procedures |
| 781 | 28.08.2006 | EMEA Publishes Comments on Draft Guidelines for Herbal Medicinal Products |
| 777 | 21.08.2006 | Report of the Annual Advisory Board Meeting of the European Compliance Academy (ECA) |
| 776 | 21.08.2006 | New EMEA Guidelines for Herbal Medicinal Products |
| 775 | 21.08.2006 | EMEA Plans Revision of NIR Guideline |
| 774 | 21.08.2006 | Annual Review 2006 |
| 771 | 10.08.2006 | European Compliance Academy (ECA) Advisory Board Establishes European Qualified Person Association |
| 770 | 09.08.2006 | EMEA Reflection Paper on PAT |
| 764 | 28.07.2006 | European Compliance Academy initiates Working Group for Rapid Microbiological Methods |
| 763 | 28.07.2006 | PIC/S revises Guide to GMP for Medicinal Products |
| 761 | 18.07.2006 | ICH Steering Committee Withdraws ICH Q1 F Guideline |
| 760 | 14.07.2006 | Qualified Person Must Confirm API-Related Notification of Changes |
| 757 | 04.07.2006 | Is There a List of Equipment for Pharmaceutical Manufacture
Approved by FDA? |
| 756 | 30.06.2006 | Revision of FDA/EU GMP ISO Matrix - ECA Good Practice Guide |
| 753 | 29.06.2006 | EMEA's View on the Implementation of RMMs for WFI and Purified Water |
| 752 | 29.06.2006 | GMP Questions and Answers from the Canadian Authority |
| 748 | 19.06.2006 | Results of the ECA Survey on Rapid Microbiological Methods - RMMs |
| 747 | 19.06.2006 | FDA Conducts Workshop for Small Pharmaceutical Businesses |
| 746 | 19.06.2006 | FDA Announces Withdrawal of 5 and Revision of 2 Guidances |
| 741 | 30.05.2006 | New FDA Science Forum Documents on Dissolution Testing |
| 740 | 30.05.2006 | Validation Requirements on the Packaging of Medical Devices |
| 739 | 30.05.2006 | DoE from the Authorities' Point of View |
| 735 | 24.05.2006 | Online Seminars Generate Big Interest: Successful Start of the GMP-Webinars |
| 734 | 24.05.2006 | New EMEA Document on Release Decisions of a Qualified Person |
| 729 | 17.05.2006 | ASTM Draft Guide: Science- and Risk-Based Approach to Qualification |
| 728 | 15.05.2006 | FDA's New Validation Approach - The Life Cycle Approach |
| 727 | 12.05.2006 | EU Requirements on Braille for Printed Packaging Materials |
| 723 | 10.05.2006 | The current thinking about Rapid Microbiological Methods and PAT |
| 722 | 09.05.2006 | Risk Management in a New EMEA Paper |
| 721 | 05.05.2006 | WHO Guidelines on GMP-Compliant Sampling |
| 720 | 03.05.2006 | The 8th European API Conference in Berlin - A Review |
| 716 | 03.05.2006 | Withdrawal: FDA's cGMP Regulation and Investigational New Drugs |
| 714 | 28.04.2006 | FDA's New Compliance Program Guidance Manual, Chapter 45 - Biological Drug Products |
| 713 | 27.04.2006 | The End of Process Validation? |
| 709 | 19.04.2006 | Validation of Computerised Systems: Answers to Frequently Asked Questions to GMP Inspectors |
| 708 | 19.04.2006 | FDA Details Its Visions of the "cGMP for the 21st Century Initiative" |
| 707 | 19.04.2006 | EMEA Plans Changes in the Field of GMP-Compliant Manufacturing of Investigational Medicinal Products |
| 704 | 11.04.2006 | Containment Systems under Discussion |
| 703 | 11.04.2006 | GMP Inspections of Computerised Systems - Which Are the Most Frequent Deficiencies? |
| 702 | 05.04.2006 | Warning Letters Report 2005 |
| 697 | 23.03.2006 | ECA Internet Survey on Rapid Microbiology |
| 696 | 23.03.2006 | EMEA plans the revision of various GMP requirements |
| 695 | 23.03.2006 | New Technical Guide of the European Pharmacopoeia for the Elaboration of Monographs published |
| 692 | 16.03.2006 | New Version 8.0 of the CD-ROM GMP Navigator Released |
| 691 | 16.03.2006 | New FDA Compliance Programme
Guidance for Inspection of API manufacturers |
| 690 | 16.03.2006 | Media Fills in the Centre of US FDA Warning Letters |
| 687 | 09.03.2006 | Finally Official: New USP Monograph on Pure Steam |
| 688 | 08.03.2006 | New EMEA Guideline on Blood and Blood Products |
| 689 | 08.03.2006 | EMEA Plans Revision of Several Guidelines as well as
New Guideline on Herbal Medicinal Products |
| 680 | 01.03.2006 | New Annex 19 "Reference and Retention Samples" Effective June 2006 |
| 679 | 28.02.2006 | New FDA Guidance for Industry: Formal Dispute Resolution: Scientific and Technical Issues Related to Pharmaceutical CGMP |
| 676 | 22.02.2006 | Current Packaging Materials Requirements |
| 675 | 22.02.2006 | The new PIC/S AIDE-MEMOIRE "INSPECTION OF BIOTECHNOLOGY MANUFACTURERS" |
| 670 | 14.02.2006 | New Information on ICH Q10 "Quality Systems" |
| 671 | 14.02.2006 | Problems with the Integration of ICH Q9 into the European Regulatory System |
| 672 | 09.02.2006 | New FDA Requirements on the Manufacture of Investigational Drugs for Phase 1 |
| 666 | 24.01.2006 | Mike Edgington Named Director for Regulatory Affairs at ECA |
| 665 | 23.01.2006 | Lubricants in the GMP and HACCP Surrounding |
| 664 | 20.01.2006 | In-Vitro Pyrogen Testing - Soon Part of the European Pharmacopoeia? |
| 657 | 02.01.2006 | New Inspection Guideline for GMP Labs |
| 658 | 02.01.2006 | New Contents of Annex 1 on Clean-Room Classification |
| 654 | 23.12.2005 | Inside News: GMP Webinars - The New Online Seminars |
| 653 | 20.12.2005 | New EMEA Document Questions the 3 Validation Batches for the First Time |
| 652 | 16.12.2005 | Third-Party GMP Audits of API Manufacturers - EMEA Gives Green Light |
| 648 | 08.12.2005 | Analysis of GMP Inspections by MHRA |
| 647 | 08.12.2005 | ICH Q9 on Quality Risk Management Now Available |
| 641 | 01.12.2005 | EU GMP Guide: New Draft for Annex 1 "Sterile Manufacturing" Published |
| 644 | 01.12.2005 | ICH Q8 Guideline Now Available in PDF Format |
| 642 | 01.12.2005 | FDA and EU Extend Confidentiality Arrangements |
| 643 | 25.11.2005 | Product Recalls Due to OOS Results |
| 636 | 21.11.2005 | ICH Q8 and Q9 Now Finalised - ICH Q10 on Quality Systems to Come |
| 635 | 21.11.2005 | Changes to the EU GMP Guide Passed |
| 629 | 25.10.2005 | EC Commission Publishes the Restructured EU-GMP Guide! |
| 631 | 25.10.2005 | Statistics on FDA Inspections |
| 630 | 24.10.2005 | Impurities in Generics - New FDA Draft Guidance for Industry |
| 625 | 17.10.2005 | ECA Good Practice Guide "FDA cGMP, EU GMP and ISO 9001 Matrix for a pharmaceutical Quality System - A GMP Roadmap -" |
| 623 | 12.10.2005 | FDA Applies for PIC/S Membership |
| 621 | 11.10.2005 | SOP by EMEA on Inspections |
| 622 | 11.10.2005 | Laboratory Activities in the Focus of FDA Inspectors |
| 616 | 06.10.2005 | New ECA Mission Published |
| 615 | 06.10.2005 | Daniel Scheidegger Appointed New ECA Chairman |
| 614 | 04.10.2005 | New FDA Developments |
| 613 | 29.09.2005 | Increase in FDA Warning Letters to European Pharmaceutical Companies |
| 608 | 20.09.2005 | Revision of the EMEA Inspection Guideline |
| 610 | 20.09.2005 | "CDER 2004 Report to the Nation" Published by FDA |
| 604 | 14.09.2005 | Revision of USP Chapter <1116> on Environmental Monitoring |
| 605 | 13.09.2005 | New USP Drafts on Pharmaceutical Water and Steam |
| 598 | 01.09.2005 | EDQM's Inspection Programme |
| 597 | 01.09.2005 | New USP Requirements with an Influence on the Handling of OOS Results |
| 596 | 01.09.2005 | New EMEA Guideline on Plastic Packaging Materials |
| 591 | 22.08.2005 | FDA Published ICH Q9 "Quality Risk Management" |
| 590 | 22.08.2005 | ECA's Annual Advisory Board Meeting in Heidelberg |
| 589 | 22.08.2005 | Two Recent Warning Letters for Manufacturers of Sterile Products |
| 588 | 15.08.2005 | FDA Published New Q-and-A on cGMP |
| 580 | 25.07.2005 | Results of Inspections of Manufacturers of Sterile Medicinal Products |
| 579 | 25.07.2005 | Which Firms Will the FDA Inspect More Frequently in the Future? |
| 578 | 22.07.2005 | Current FDA Opinions on Regulatory Affairs, Inspections and GMP |
| 574 | 05.07.2005 | Young scientists can participate in ECA Biotech Conference free of charge! - Johnson & Johnson donates 5 participations |
| 573 | 04.07.2005 | Comparability of Biotechnological Products - New Guidance Documents from FDA and EMEA |
| 572 | 04.07.2005 | Restructuring the EG GMP Guide |
| 565 | 30.05.2005 | ICH Q9 to Become an Annex to the EU GMP Guide after Being Passed |
| 563 | 30.05.2005 | GMP Trends: FDA Offices Outside USA? Quo Vadis ICH Q10? |
| 562 | 25.05.2005 | Biological Product Inspection Issues and Regulatory Update |
| 559 | 24.05.2005 | New GAMP Good Practice Guide "Validation of Laboratory Computerized Systems" Published |
| 558 | 20.05.2005 | Barr Judgement on the Internet |
| 557 | 20.05.2005 | Third-Party GMP Audit at Genzyme Pharmaceuticals |
| 553 | 11.05.2005 | New Version 7.0 of the CD-ROM GMP Navigator Has Been Released |
| 552 | 10.05.2005 | EMEA and FDA Intensify Their Co-operation |
| 551 | 09.05.2005 | New: The ISPE Good Practice Guide: Assessing the Particulate Containment Performance of Pharmaceutical Equipment |
| 550 | 25.04.2005 | ICH Q8 "Pharmaceutical Development" - Background and Important Aspects of Implementation |
| 549 | 25.04.2005 | Summary of Changes in the Notice to Applicants |
| 539 | 12.04.2005 | FDA Publishes a New Draft Guideline on Impurities in Raw Materials |
| 543 | 06.04.2005 | ICH Q 9 on Quality Risk Management published! |
| 538 | 01.04.2005 | Validation of Computer-Based HPLC Systems |
| 537 | 01.04.2005 | Stronger Emphasis of Supplier Audits Concerning Packaging Materials |
| 530 | 11.03.2005 | New GMP Initiative Published by EU Commission and EMEA |
| 526 | 08.03.2005 | New Draft for a USP Monograph on the Qualification of Analytical Instruments |
| 525 | 07.03.2005 | FDA Findings During Inspections on Design and Construction of Equipment |
| 524 | 03.03.2005 | US FDA GRANTED OBSERVER STATUS TO EUROPEAN PHARMACOPOEIA COMMISSION |
| 519 | 22.02.2005 | EMEA: Activities of Inspections Sector |
| 521 | 22.02.2005 | Annual Review 2004 |
| 515 | 15.02.2005 | New APIC Guidance on the Qualification of Existing Equipment Published |
| 514 | 14.02.2005 | FDA Warning Letter Report 2004 Published |
| 513 | 10.02.2005 | Recently published APIC Industry Best Practice documents |
| 509 | 02.02.2005 | Frequently Requested Inspection Documents
on FDA's Website |
| 507 | 02.02.2005 | PAT (Process Analytical Technology) in Europe |
| 508 | 01.02.2005 | EMEA Publishes "cGMP Notes" |
| 496 | 29.11.2004 | FDA White Paper: Innovation and Continuous Improvement in Pharmaceutical Manufacturing |
| 488 | 10.11.2004 | FDA and EMEA Presentation on Hot GMP and Regulatory Topics |
| 487 | 26.10.2004 | Analysis of the Changes Concerning Process Simulation in FDA's New Aseptic Processing Guide |
| 486 | 25.10.2004 | Which Areas Are Evaluated During FDA Inspections of Laboratories? |
| 485 | 22.10.2004 | New: ICH Q7A - Side-by-Side Comparison with APIC's How-to-Do Document |
| 481 | 15.10.2004 | FDA's Final PAT Guidance - Which Changes Have Been Made? |
| 480 | 15.10.2004 | New FDA Draft Guidance on cGMP for Combination Products |
| 479 | 14.10.2004 | FDA-Meeting About Follow-on Protein Products |
| 473 | 05.10.2004 | Risk-ranking Model for Prioritising GMP Inspections - FDA's Pilot Model |
| 475 | 30.09.2004 | FDA Publishes 5 New Guidances |
| 472 | 29.09.2004 | ICH Q9 "GMP Risk Management" |
| 470 | 29.09.2004 | FDA's Dr. Nasr: "I think we are changing the paradigm of how to assess quality of pharmaceuticals in the U.S. and in the world" |
| 463 | 13.09.2004 | FDA Statement on Media Failures |
| 461 | 10.09.2004 | Extension of the Scope of Pharmacopoeia Reference Standards Planned |
| 462 | 09.09.2004 | EU: Quality of Drug Substance in the Dossier - Revised CPMP Guidelines |
| 454 | 24.08.2004 | New Annex 2 to Note for Guidance on Process Validation |
| 455 | 23.08.2004 | Dissolution Testing in Human Drug CGMP Notes |
| 447 | 06.08.2004 | New Q-and-A Website on cGMP by FDA |
| 443 | 04.08.2004 | FDA Award to Dr Lothar Hartmann and Dr Norman Franklin! |
| 445 | 03.08.2004 | The New FDA Strategy - The Speech of the New FDA Acting Commissioner |
| 444 | 02.08.2004 | New CPMP Guideline on Impurities in Pharmacopoeial Substances |
| 438 | 21.07.2004 | Draft for a New Annex 19 to the EU GMP Guide Published |
| 436 | 16.07.2004 | Inspection Findings Regarding Change Control in Production and Engineering |
| 435 | 15.07.2004 | EMEA Road Map: Information on Future GMP and GCP Inspections |
| 432 | 01.07.2004 | FDA Warning Letter Report |
| 431 | 30.06.2004 | New CPMP Guideline on Plastic Primary Packaging Materials |
| 427 | 18.06.2004 | FDA Inspection Findings Regarding Manufacturing Equipment |
| 424 | 27.05.2004 | New FDA Draft Guidances on "Chemistry, Manufacturing, and Control Information (CMC)" |
| 422 | 26.05.2004 | Latest News on MRA Agreements |
| 420 | 24.05.2004 | Epilogue to the CONCEPT HEIDELBERG Seminar: Cleanroom Technology in the Focus of the New Guidances "EU GMP Guide Annex 1" and "Aseptic Guide" by the FDA (Held in Mannheim on 4 November 2003) |
| 419 | 07.05.2004 | Good Distribution Practice and Cold Chain Management –
Current Regulatory Initiatives |
| 418 | 06.05.2004 | Computer Validation: Frequently Asked Questions on GMP/FDA Compliance |
| 417 | 05.05.2004 | EU Publishes the New EU Directive 2004/27 - Consequences for the GMP-regulated Environment |
| 413 | 22.04.2004 | Public Meeting on Electronic Records; Electronic Signatures (Part 11), 11 June 2004, Washington D.C. |
| 411 | 22.04.2004 | New FDA Initiative on Process Validation |
| 408 | 19.04.2004 | Top Ten of 483 Findings by the FDA in Fiscal Year 2003 |
| 407 | 19.04.2004 | FDA Presentation on Risk Management in Drug Quality |
| 409 | 16.04.2004 | FDA Has Published Additional HUMAN DRUG CGMP NOTES |
| 403 | 06.04.2004 | Deviations Regarding Documentation in FDA Warning Letters |
| 402 | 05.04.2004 | GHTF Guideline on Process Validation |
| 401 | 31.03.2004 | Revision of Directive 2001/83/EC - Consequences for the API Industry |
| 397 | 12.03.2004 | New Guideline by the Global Harmonization Task Force (GHTF) on Risk Analysis |
| 396 | 11.03.2004 | What Does an Inspector Expect of GMP Training and of a GMP Training System? |
| 391 | 23.02.2004 | GMP/FDA Requirements on HPLC Systems in the Lab |
| 390 | 23.02.2004 | New FDA Requirements on Filter Validation |
| 386 | 12.02.2004 | New Requirements on the Validation of Sterility Tests |
| 385 | 11.02.2004 | New Variations Regulations 1084/2003 and 1085/2003 |
| 372 | 10.02.2004 | The New GAMP Good Practice Guide "Validation of Process Control Systems" (VPCS) |
| 384 | 09.02.2004 | Annual Review 2003 |
| 383 | 05.02.2004 | New Guidelines and Regulations for the Blood-Processing Industry |
| 382 | 04.02.2004 | Evaluation of Warning Letters Concerning Water Systems, Pipes, Dead Legs, and Valves |
| 381 | 03.02.2004 | New: Addition to the EU GMP Guide |
| 371 | 12.12.2003 | FDA Develops Quality Systems Guidance (Labcompliance News from Dr Ludwig Huber) |
| 370 | 11.12.2003 | Adjustment versus Modification - Interpretation of the Ph.Eur. Requirements |
| 369 | 10.12.2003 | ICH Q8 and ICH Q9 Coming Soon! |
| 428 | 01.12.2003 | 6th APIC 2003 |
| 365 | 14.11.2003 | EMEA Plans Revision of the Note for Guidance on Plastic Primary Packaging Materials |
| 364 | 13.11.2003 | Current Inspection Findings of the British Supervisory Authority MHRA (Formerly MCA) |
| 355 | 20.10.2003 | FDA Requirements on the Qualification of Component Suppliers |
| 353 | 13.10.2003 | New PIC/S Guidance on Computer Validation |
| 351 | 22.09.2003 | Analysis of Our Internet Survey of 28 August 2003 |
| 348 | 18.09.2003 | First Consequences for Process Validation and Equipment Qualification According to the New FDA Draft Guidance on Aseptic Processing |
| 347 | 08.09.2003 | FDA Draft Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing |
| 346 | 08.09.2003 | Final Version: Guidance for Industry, Part 11, Electronic Records; Electronic Signatures - Scope and Application |
| 345 | 08.09.2003 | NEW: PAT (Process Analytical Technology) Draft Guidance from FDA! |
| 339 | 28.08.2003 | Is it possible to fulfil the new requirements of the revised Annex 1 to the EC Guide on the Manufacture of Sterile Medicinal Products? |
| 340 | 27.08.2003 | FDA's Expectations on the Training Documentation of Laboratory Staff |
| 341 | 26.08.2003 | Insight into the New ISPE Guide: "Assessing the Particulate Containment Performance of Pharmaceutical Equipment" |
| 335 | 06.08.2003 | Will the GMP Regulations Be Harmonised Worldwide? |
| 330 | 22.07.2003 | Heidelberg - an Attractive Conference Venue with Optimal Accessibility via Frankfurt |
| 329 | 21.07.2003 | FDA's System-based Approach to Inspections as Reflected in the Warning Letters |
| 328 | 18.07.2003 | Commission Directive 2003/63/EC: The New Annex 1 to Directive 2001/83/ EC |
| 321 | 18.06.2003 | FDA Presents Its Analysis of Observations Noted on 483 Forms |
| 318 | 17.06.2003 | Batch Release and Certification in the European Context - The MRA between Europe and Switzerland |
| 316 | 16.06.2003 | CPMP Guideline on NIR Adopted |
| 315 | 20.05.2003 | New Release: GMP Navigator on CD-ROM 5.0 |
| 311 | 02.05.2003 | VDI Guideline 2083 Sheet 8 "Cleanroom Suitability of Operating Materials" |
| 310 | 30.04.2003 | Changes in the Application Form for a Marketing Authorisation |
| 309 | 29.04.2003 | FDA's Risk-based Approach - Tools for Risk Analysis |
| 301 | 04.04.2003 | Risk Classification of GMP Deviations |
| 300 | 03.04.2003 | Annual Review 2002 |
| 299 | 02.04.2003 | Warning Letters 2002: The Top 10 Complaints Regarding 21 CFR § 211 |
| 294 | 26.02.2003 | FDA Withdraws All Part 11 Guides and Publishes a New Draft |
| 293 | 25.02.2003 | MRA between EU and Canada Came into Force on 1 February 2003! |
| 292 | 24.02.2003 | Revision of the PIC/S Document PH 4/93 on the Preparation of a Site Master File |
| 289 | 17.02.2003 | ISPE's White Paper on "Risk-Based Approach to 21 CFR Part 11" |
| 288 | 15.02.2003 | Revision of the EMEA Guideline on Stability Testing
of Existing Active Substances and Related Finished Products |
| 287 | 14.02.2003 | FDA Withdraws Part 11 Guide! |
| 282 | 03.02.2003 | Social Events |
| 278 | 13.01.2003 | PIC/S Recommendation on Sterility Testing Revised |
| 277 | 10.01.2003 | HPLC in FDA Warning Letters |
| 273 | 17.12.2002 | EU-GMP Guide Annex 1 (Sterile Medicinal Products) to Be Revised |
| 269 | 11.12.2002 | 5th European API Conference - Review |
| 268 | 04.12.2002 | Poll on 21 CFR Part 11 |
| 267 | 03.12.2002 | New WHO Guideline on GMP-compliant Storage - "Good Storage Practices" |
| 266 | 02.12.2002 | Wallhäußer Award for Drug Quality and Safety Given to Dr L. Huber |
| 262 | 14.11.2002 | Systems Inspections 2002 - FDA's New Approach to Inspections |
| 261 | 13.11.2002 | FDA's New Draft Guidance on Electronic Copies of Electronic Records |
| 258 | 06.11.2002 | Revision of the Variations Regulation - New Proposal released on 25 October 2002 - New Categories of EU-Variations |
| 256 | 30.10.2002 | Heidelberg - an Attractive Conference Venue with Optimal Accessibility via Frankfurt |
| 251 | 29.10.2002 | Warning Letter Report - Data Base Publication |
| 255 | 28.10.2002 | First Analysis of the New FDA Draft on Aseptic Processing |
| 253 | 25.10.2002 | Part-11-Compliance CD Finished |
| 249 | 16.10.2002 | Advanced GMP Search Function |
| 248 | 15.10.2002 | The Rapid Alert System for the PIC/S Member Countries |
| 245 | 30.09.2002 | Long-awaited Draft Guide on Aseptic Processing Published |
| 243 | 27.09.2002 | FDA Slides on ICH Q7A Available |
| 242 | 26.09.2002 | Calibration Management Guide Published by GAMP |
| 241 | 25.09.2002 | 2 Position Papers on APIs published by APIC |
| 240 | 24.09.2002 | 21 CFR 211.198 - Complaint Warning Letters in Detail |
| 235 | 17.09.2002 | Guidances for Part 11 published by FDA on September 5, 2002 |
| 232 | 04.09.2002 | New Initiative by FDA |
| 229 | 28.08.2002 | New PIC/S Document PI 009-1 "Inspection of Utilities" came into force as AIDE MEMOIRE on 1 July 2002 |
| 228 | 27.08.2002 | New PIC/S Recommendation PI 014-1: "Isolators used for aseptic processing and sterility testing" |
| 227 | 27.08.2002 | Europe's Answer to the FDA Investigational Manual |
| 226 | 26.08.2002 | Sterility Testing: PIC/S Document PE 001-2 with Recommendations for GMP Inspectors |
| 225 | 24.08.2002 | New Monograph on Near Infrared Spectroscopy in the USP |
| 224 | 23.08.2002 | Draft EMEA Note for Guidance on DMF Procedures |
| 218 | 05.08.2002 | FDA Requirements to Shipping and Storage Containers |
| 217 | 03.08.2002 | EMEA Guideline on Water for Pharmaceutical Use Revised |
| 216 | 02.08.2002 | List of Part-11 Suppliers in the FDA Dockets |
| 211 | 03.07.2002 | Revision of the Directive 91/356/EEC |
| 210 | 02.07.2002 | The PECA Agreements on GMP |
| 209 | 01.07.2002 | Proposed Changes to the Variations Regulation - New Categories of EU Variations |
| 205 | 18.06.2002 | Warning Letter Report: Overview of the FDA Warning Letters of the Year 2001 |
| 199 | 24.05.2002 | Quality Management System - The Experience of a Medium-sized Cosmetics Company |
| 201 | 23.05.2002 | Web-based Training Course "A Tour of FDA" |
| 200 | 22.05.2002 | Check List for Part-11 Systems |
| 193 | 07.05.2002 | CTD - Transition Period Runs Out on 1 July 2003 |
| 192 | 03.05.2002 | FDA: Federal Standard 209 Replaced |
| 188 | 11.04.2002 | New PIC/S Draft Guideline on Computer Validation |
| 187 | 08.04.2002 | FDA-compliant Seal Materials in the Endurance Test |
| 186 | 05.04.2002 | GMP in Biotechnology |
| 185 | 04.04.2002 | New FDA Guidance on 21 Cfr Part 11 - »Time Stamps« |
| 184 | 03.04.2002 | New ICH Guidelines on Stability Testing |
| 177 | 08.03.2002 | New Draft of Annex 13 - Manufacture of Investigational Medicinal Products |
| 176 | 02.03.2002 | Do You Already Know the PIC/S Document PI 006-1? |
| 174 | 28.02.2002 | Revision of the IPEC 'GMP Guide for Bulk Pharmaceutical Excipients' - An important contribution towards drug safety |
| 173 | 28.02.2002 | On 1 February 2002 the FDA System-based Inspections Came into Force |
| 175 | 28.02.2002 | Amendment to a European Directive Concerning Traditional Herbal Medicinal Products |
| 172 | 27.02.2002 | What now, MRA? |
| 198 | 17.02.2002 | Annual Review 2001 |
| 165 | 28.01.2002 | Revision of the Note for Guidance on Chemistry of the New Active Substance |
| 160 | 09.01.2002 | New Draft for a CPMP Guideline on Near Infrared Spectroscopy: NIRS in the Dossier for a Marketing Authorisation |
| 159 | 08.01.2002 | "Note for Guidance on Quality of Water for Pharmaceutical Use" |
| 155 | 17.12.2001 | Preview of Standards for Cleanroom Technology |
| 153 | 13.12.2001 | Validation of Analytical Methods: Intermediate Precision |
| 152 | 12.12.2001 | Quality System Inspection Technique |
| 151 | 08.12.2001 | New Version of Compilation of Community Procedures on Inspections and Exchange of Information |
| 146 | 15.11.2001 | Professional Certification Programme |
| 144 | 12.11.2001 | GMP Deficiencies in Europe |
| 143 | 09.11.2001 | Essentials of the 4th CEFIC/APIC European Conference on
Active Pharmaceutical Ingredients |
| 139 | 10.10.2001 | Acceptance of Near Infrared Spectroscopy (NIRS) by the Regulatory Authorities |
| 140 | 09.10.2001 | FDA Draft Guidance for 21 CFR Part 11 |
| 135 | 01.10.2001 | New Books on Pharmaceutical Quality Assurance |
| 132 | 13.09.2001 | Help with Electronic Records and Electronic Signatures |
| 131 | 12.09.2001 | New Draft Recommendation on Isolators Used for Aseptic Processing and Sterility Testing |
| 128 | 21.08.2001 | Measurement Uncertainty |
| 127 | 20.08.2001 | Annex 1 geändert |
| 121 | 25.07.2001 | ICH Guideline Published as Annex to the EU Guide to Good Manufacturing Practice, Eudralex Volume 4 |
| 120 | 24.07.2001 | Current Trends in FDA Warning Letters |
| 119 | 19.07.2001 | 4 New Annexes to EC GMP Guideline Finalised |
| 115 | 09.07.2001 | New Books on Pharmaceutical Automation |
| 114 | 02.07.2001 | New requirements for pharmaceutical water in Europe |
| 113 | 30.06.2001 | New FDA inspection system |
| 112 | 26.06.2001 | Zwei neue Bücher von Dr. Michael Jahnke: Mikrobiologisches und Umgebungsmonitoring bei der Media Fill Validierung |
| 106 | 06.04.2001 | HACCP - getting closer and closer |
| 105 | 03.04.2001 | News from the USA: BACPAC I now approved |
| 104 | 02.04.2001 | FDA-Drug Manufacturing Inspections (Pilot Program) |
| 100 | 02.04.2001 | CD-ROM GMP Navigator 3.0 just released! |
| 98 | 01.03.2001 | Third Party Audit as a Part of Shared Audits |
| 97 | 01.03.2001 | Final Draft of Annex 15 published! |
| 93 | 26.02.2001 | ECA continues its success in 2000 |
| 91 | 06.02.2001 | New European Pharmacopoeia specifications for the system suitability test and for the delimitation between adjustment and modification of a method |
| 90 | 06.02.2001 | Annex 15 coming.....Annex 15 coming.... |
| 89 | 19.01.2001 | PIC/S Committee Meeting on 24 October 2000 |
| 84 | 18.12.2000 | FDA Requirements to Electronic Signatures and
Records in the Laboratory |
| 81 | 27.11.2000 | Validation - updating the standards |
| 78 | 25.10.2000 | New book on Pharmaceutical Quality Systems |
| 73 | 30.09.2000 | 3rd European GMP Conference on Active Pharmaceutical Ingredients - Review - |
| 72 | 27.09.2000 | New: EMEA concept paper on water |
| 71 | 25.09.2000 | MRA between EC and USA doomed to failure? |
| 70 | 16.09.2000 | New: FDA guideline on herbal drug products |
| 65 | 03.08.2000 | Worldwide harmonized GMP for active pharmaceutical ingredients published as "Consensus Draft Guideline" |
| 56 | 20.03.2000 | CD-ROM GMP-Navigator 2.0 - Free of charge for all participants in an ECA event |
| 51 | 27.12.1999 | 1999 ECA's first year a great success |
| 49 | 12.12.1999 | Trends in validation - News from PIC/S and FDA - |
| 48 | 12.11.1999 | Pressemitteilung - APIC - 2nd European GMP Conference on Active Pharmaceutical Ingredients |
| 41 | 05.10.1999 | European Conference on Computer Validation - Conference Review - |
| 35 | 22.06.1999 | Conference Review on the European Validation Conference, May 4-5 1999, Berlin, Germany |
| 22 | 30.12.1998 | Conference Report 2nd European GMP Conference
Berlin, December 2 - 3, 1998 |
| 12 | 25.09.1998 | Press Release "First European GMP Conference on Active Pharmaceutical Ingredients", 9-11 September 1998, Brüssel |