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Nr.Title
1869Clozapine Tablets in Vivo Bioequivalence and in Vitro Dissolution Testing (Issued 06/17/2005, Reposted 06/17/2005)
1870Corticosteroids, Dermatologic (topical) In Vivo (Issued 6/2/1995, Posted 3/6/1998)
1871Dissolution Testing of Immediate Release Solid Oral Dosage Forms (Issued 8/1997, Posed 8/25/1997)
1872Extended Release Oral Dosage Forms: Development, Evaluation and Application of In Vitro/In Vivo Correlation (Issued 9/1997, Posted 9/26/1997)
1873Common Technical Document - Quality Questions and Answers/Location Issues
1874CTD General Questions and Answers
1875M4: Organization of the CTD
1877GUIDELINE ON EPIDEMIOLOGICAL DATA ON BLOOD TRANSMISSIBLE INFECTIONS
1884Food-Effect Bioavailability and Fed Bioequivalence Studies (Issued 12/2002, Posted 1/30/2003)
1885Metaproterenol Sulfate and Albuterol Metered Dose Inhalers in Vitro (Issued 6/27/1989, Posted 3/2/1998)
1887Potassium Chloride (slow-release tablets and capsules) In Vivo Bioequivalence and In Vitro Dissolution Testing (Revised 6/6/1994, Posted 6/22/1998)
1888Statistical Approaches to Establishing Bioequivalence (Issued 2/2001; Posted 2/1/2001)
1889Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System (Issued 8/2000, Poste 8/31/2000)
1890Bioavailability and Bioequivalence Studies for Nasal Aerosols and Nasal Sprays for Local Action (Posted 4/2/2003)
1892Expiration Dating of Unit-Dose Repackaged Drugs: Compliance Policy Guide
1893Conjugated Estrogens, USP-ÖC-MS-Method for Both Qualitative Chemical Characterization and Documentation of Qualitative Pharmaceutical Equivalence (Issued 3/6/2000, Posted 3/6/2000)
1900Potassium Chloride Modified-Release Tablets and Capsules: In Vivo Bioequivalence and In Vitro Dissolution Testing (Issued 8/2002, Posted 8/6/2002)
1902Analytical Procedures and Methods Validation (Issued 8/2000, Posted 8/30(2000)
1903Comparability Protocols - Chemistry, Manufacturing, and Controls Information (Issued 2/2003, Posted 2/20/2003)
1904Drugs, Biologics, and Medical Devices Derived from Bioengineering Plants for Use in Humans and Animals (Posted 9/11/2003)
1905Drug Product: Chemistry, Manufacturing, and Controls Information (Issued 1/2003, Poted 1/28/2003)
1906Drug Substance: Chemistry, Manufacturing, and Controls Information (Issued 1/2003, Posted 1/28/2003)
1907Interpreting Sameness of Monoclonal Antibody Products under the Orphan Drug Regulations (Issued 1/2004, Posted 1/6/2004)
1908Liposome Drug Products: Chemistry, Manufacturing, and Controls: Human Pharmacokinetics, Bioavailability, and Labeling Documentation (Issued 7/2002, Posted 8/20/2002)
1935Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations
1941APIC - List of Abbreviations & Acronyms
1942APIC - Good manufacturing practices for Active ingredient manufacturers, with EFPIA, 1996
1943APIC - Quality Management System for Active pharmaceutical Ingredient manufacturers - Integrating GMP into ISO 9001, December 1997
1944APIC - Manufacture of sterile active pharmaceutical ingredients - guidance 1999
1945APIC - Cleaning Validation in Active pharmaceutical Ingredient manufacturing plants - Policy, 1999
1946APIC - Good Manufacturing Practices in Active Pharmaceutical Ingredients Development, 1999
1947APIC - Guidance on aspects of cleaning validation in active pharmaceutical ingredient plants, guidance 2000
1948APIC - GMPs for APIs: “How to do” Document - Interpretation of the ICH Q7a Guide - Version 5: Final
1949APIC - Computer validation Guide, December 2002
1950APIC - Auditing Guide, September 2008
1951Auditing Guide Appendix A – Secrecy Agreement
1952Auditing Guide Appendix B – Pre-Audit Questionnaire
1953Auditing Guide Appendix C – Aide Mémoire
1954Auditing Guide Appendix D – Audit Report Template
1955APIC - Parametric Release document, December 2002
1970CPMP/QWP/450/03 corr Annexes to Specifications for class 1 and class 2 residual solvents in active substances (Adoped by CHMP July 2004)
1971CHMP/QWP/297/97 Rev. 1 corr Guideline on Summary of Requirements for Active Substances in the Quality Part of the Dossier
1972CPMP/QWP/1529/04 CPMP Guideline on Control of Impurities of Pharmacopoeial Substances (Adopted for implementation, April 2004)
1973CPMP/QWP/227/02 Rev 1 (EMEA/CVMP/134/02 Rev 1) Guideline on Active Substance Master File Procedure (February 2004)
1975CPMP/QWP/609/96 Rev. 1 Note for guidance on Declaration of Storage Conditions for Medicinal Products Particulars and Active Substances (Annex to note for Guidance on Stability Testing of New Active Substances and Medicinal Products, Annex to Note for Guidance on Stability of Existing Active Substances and Related Finished Products) (Date of coming into operation October 2003). Rev 2 withdrawn.
1976CPMP/QWP/130/96 Rev. 1 Note for guidance on Chemistry of the New Active Substance. (CPMP adopted December 2003)
1977CPMP/QWP/122/02 Rev.1 Note for guidance on Stability Testing of Existing Active Substances and Related Finished products (Adoption by CPMP December 2003)
1978CPMP/QWP/3309/01 (EMEA/CVMP/961/01) Note for Guidance on the Use of Near Infrared Spectroscopy by the Pharmaceutical Industry and the Data to be forwarded in the Part II of the Dossier for a Marketing Authorisation (Adopted by CPMP/CVMP February 2003)
1979CPMP/QWP/158/01 Revision (CVMP/115/01) Note For Guidance on Quality of Water for Pharmaceutical Use (Revision adopted by CPMP/CVMP May 02)
1980CPMP/QWP/848/96 (EMEA/CVMP/598/99) Note for Guidance on Process Validation (CPMP/CVMP Adopted Feb. 01)
1981CPMP/QWP/8567/99 Explanatory Note on the Operation of Two-Year Transition Period for Application of Note for Guidance on Residual Solvents to Marketed Products
1982CPMP/QWP/576/96 Note for Guidance on Stability testing for a type II variation to a Marketing Authorisation (CPMP adopted April. 98)
1983CPMP/QWP/576/96 - Rev 1 Guideline on Stability Testing for Applications for Variations to a Marketing Authorisation
1985CPMP/SWP/QWP/4446/00 Note for Guidance on Specification Limits for Residues of Metal Catalysts, (Re-released for consultation June 2002) Corrigendum
1986Botanical Drug Products
1988Demonstration of Comparability of Human Biological Products, Including Therapeutic Biotechnology-derived Products Center for Biologics Evaluation and Research (CBER) Center for Drug Evaluation and Research (CDER) APRIL 1996
1989Development of new stereoisomeric drugs
1990Drug Master Files for Bulk Antibiotic Drug Substances
1991Drug Master Files, Current DMF Information
2002Changes to an Approved NDA or ANDA; Specifications – Use of Enforcement Discretion for Compendial Changes (Issued 11/19/2004, Posted 11/19/2004)
2012Corrigendum (Official Journal L 302, 20/11/2003 p. 40 DE).
201498/81/EC - Council Directive 98/81/EC of 26 October 1998 amending Directive 90/219/EEC on the contained use of genetically modified micro-organisms (Official Journal L 330, 5/12/1998 p. 13 - 31).
20152004/27/EC - Directive 2004/27/EC Amended by Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004 amending Directive 2001/83/EC on the Community code relating to medicinal products for human use (Official Journal L 136, 30/4/2004 p. 34 - 57).
20172003/94/EC - Commission Directive 2003/94/EC of 8 October 2003 laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use and investigational medicinal products for human use (Official Journal L 262, 14/10/2003 p. 22 - 26).
2018Guidance for Industry: Testing Limits in Stability Protocols for Standardized Grass Pollen Extracts
2019Council Regulation (EC) No 2743/98 of 14 December 1998 amending Regulation (EC) No 297/95 on fees payable to the European Agency for the Evaluation of Medicinal Products (Official Journal L 345, 19/12/1998 P. 3 - 8 CONSLEG - 95R0297 - 19/12/1998 - 15 p.).
2020Commission Regulation (EC) No 494/2003 of 18 March 2003 amending Council Regulation (EC) No 297/95 on the fees payable to the European Agency for the Evaluation of Medicinal Products
2021COM/2003/839 Commission Communication on parallel imports of proprietary medicinal products for which marketing authorisations have already been granted. [Update of the 1982 Commission Communication].
2023EC/726/2004- Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency
2032Questions and Answers on Current Good Manufacturing (cGMP) for Drugs
2042ANDAs: Pharmaceutical Solid Polymorphism
2047Guidance for Industry Product Recalls, Including Removals and Corrections
2059Annex 19: Reference and Retention Samples
2060Q8(R2) Pharmaceutical Development
2070APIC - Qualification of existing equipment (November 2004)
2071APIC - Technical Change Control Guideline 2004 (October 2004)
2072Recommendation on the Need for Revision of (CHMP) >Note for Guidance on Investigation of Bioavailability and Bioequivalence> CPMP/EWP/QWP/1401/98
2073The APIC Audit Programme, January 2008
2075Guideline on the Use of the CTD Format in the Preparation of a Registration Application for Traditional Medicinal Products
2076Bioequivalence Recommendations for Specific Products
2081Testing of Glycerin for Diethylene Glycol
2083Concept Paper on Revision of the Note for Guidance on the Use of Near Infrared Spectroscopy by the Pharmaceutical Industry and the Data Requirements for new Submissions and Variations
2084Procedure for the Preparation of Community Monographs for Traditional Herbal Medicinal Products
2085Procedure for the Preparation of Community Monographs for Herbal Medicinal Products with Well-Established Use
2086Procedure for Worksharing - Quality Variations
2096Guidance for Industry, FDA Staff, and October 4, 2004 FDA, regulated industry, and Division of Small Third Parties; Implementation of the third parties, Manufacturers, Inspection by Accredited Persons International and Program Under the Medical Device User Consumer Assistance, Fee and Modernization Act of 2002;Accreditation Criteria
2097Medical Device User Fee and Modernization Act of 2002, Validation Data in Premarket Notification Submissions (510(k)s) for Reprocessed Single-Use Medical Devices, June 1, 2004
2103Audit Language Requirements (Guidelines for Regulatory Auditing of Quality Systems of Medical Device Manufacturers - Part 1: General Requirements - Supplement 1)
2104MRA EG-Canada
2105Sectoral annex for pharmaceutical good manufacturing practices (GMP) Joint Sectoral Committee Meeting / EC - U. S. MUTUAL RECOGNITION AGREEMENT : Sectoral Annex for Pharmaceutical Good Manufacturing Practices (GMPs) - Joint Summary (21/05/99)
2106Council decision of of 8 October 2002 amending Decision 98/566/EC on the conclusion of an Agreement on mutual recognition between the European Community and Canada
2107Agreement on mutual recognition in relation to conformity assessment, certificates and markings between the European Community and Australia
2108Council decision of of 8 October 2002 amending Decision 98/508/EC on the conclusion of an Agreement on mutual recognition in relation to conformity assessment, certificates and markings between the European Community and Australia
2109Agreement on mutual recognition in relation to conformity assessment between the European Community and New Zealand
2110Council decision of of 8 October 2002 amending Decision 98/509/EC on the conclusion of an Agreement on mutual recognition in relation to conformity assessment between the European Community and New Zealand
2111Council decision of of 8 October 2002 amending Decision 2001/747/EC concerning the conclusion of the Agreement on Mutual Recognition between the European Community and Japan
2112Commission decision No 2/2002 of 8 January 2003 of the Committee established under the Agreement between the European Community and the Swiss Confederation on mutual recognition in relation to conformity assessment on the modification of the Annex 1 of the Agreement
2113Commission decision No 1/2003 of 28 January 2003 of the Committee established under the Agreement between the European Community and the Swiss Confederation on Mutual Recognition in relation to Conformity Assessment on the establishment of the list of conformity assessment bodies recognised under the Agreement
2114Corrigendum to Decision No 1/2003 (2003/128/EC) of 28 January 2003 of the Committee established under the Agreement between the European Community and the Swiss Confederation on mutual recognition in relation to conformity assessment on the establishment of the list of conformity assessment bodies recognised under the Agreement
2134Reflection paper on a proposed solution for dealing with minor deviations from the detail described in the Marketing Authorisation for Human and Veterinary Medicinal products (including biological products)
2137Guidelines on active pharmaceutical ingredient master file procedure
2176Q9 Quality Risk Management
2200Guidance for Industry and FDA Staff: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices
2222Bar Code Label Requirements - Questions and Answers Posted: 6/7/2005, Publish Date: 6/7/2005
2224Q5E Comparability of Biotechnological/Biological Products Subject to Changes in Their Manufacturing Process
2231Guidance Concerning the Braille Requirements for Labelling and the Package Leaflet
2232Guidance for Industry Nonclinical Studies for the Safety Evaluation of Pharmaceutical Excipients
2233Environmental Risk Assessment of Medicinal Products for Human Use
2238Radiopharmaceutical products
2239Application of Hazard Analysis and Critical Control Point (HACCP) Methodology in Pharmaceuticals
2242WHO: Quality assurance of pharmaceuticals: a compendium of guidelines and related materials
2246Good trade and distribution practices for pharmaceutical starting materials
2247WHO pharmaceutical starting materials certification scheme (SMACS): guidelines on implementation
2248Certification scheme on the quality of pharmaceutical products moving in international commerce
2249Procedure for assessing the acceptability, in principle, of procurement agencies for use by United Nations agencies
2250Guidelines for the preparation of a procurement agency information file
2251Interim guidelines for the assessment of a procurement agency
2252Guide to good storage practices for pharmaceuticals
2253Quality assurance of pharmaceuticals: a compendium of guidelines and related materials
2254Quality system requirements for national GMP inspectorates
2255Pre-approval inspections
2256Inspection of pharmaceutical manufacturers
2257Inspection of drug distribution channels
2258Guidance on GMP: Inspection Report
2259Model Certificate of GMP
2260Basic tests for drugs : pharmaceutical substances, medicinal plant materials and dosage forms
2261The International Pharmacopoeia
2262Index of national, regional and international pharmacopoeias
2263Lists of available International Chemical Reference Substances and International Infrared Reference Spectra
2264Recommendations on Risk of Transmitting Animal Spongiform Encephalopathy Agents via Medicinal Products
2265The International Pharmacopoeia: revised concepts and future perspectives
2266Orally Disintegrating Tablets
2267Considerations for requesting analyses of drug samples
2268Model certificate of analysis
2269Good practices for pharmaceutical quality control laboratories
2270Procedure for assessing the acceptability, in principle, of quality control laboratories for use by United Nations agencies
2271Guidelines for preparing a laboratory information file
2272Quality control methods for medicinal plant materials
2273GAMP Good Practice Guide Electronic Data Archiving
2274Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile
2275Guidance on the selection of comparator pharmaceutical products for equivalence assessment of interchangeable multisource (generic) products
2276Stability testing of active pharmaceutical ingredients and finished pharmaceutical products
2277Guidelines on packaging for pharmaceutical products
2278Guidelines on import procedures for pharmaceutical products
2283Implementatin of risk management principles and activities within a QMS
2284Draft Guidance for Industry and FDA Current Good Manufacturing Practice for Combination Products
2285Medical Device User Fee and Modernization Act of 2002, Validation Data in Premarket Notification Submissions (510(k)s) for Reprocessed Single-Use Medical Devices
2286Quality System Information for Certain Premarket Application Reviews; Guidance for Industry and FDA Staff
2287Medical Device Use-Safety: Incorporating Human Factors Engineering into Risk Management
2289HUMAN FACTORS PRINCIPLES FOR MEDICAL DEVICE LABELING
2298Aide Memoire on GMP PARTICULARITIES IN THE MANUFACTURE OF MEDICINAL PRODUCTS TO BE USED IN CLINICAL TRIALS ON HUMAN SUBJECTS (PI 021-2) Sept 2007
2299Aide Memoire on INSPECTION OF BIOTECHNOLOGY MANUFACTURES (PI 024-2) Sept 2007
2300Aide Memoire on Inspection of Quality Control Laboratories(PI 023-2) Sept 2007
2301Updated 510(k) Sterility Review Guidance K90-1; Final Guidance for Industry and FDA
2302Premarket Notifications [510(k)]for Biological Indicators Intended to Monitor Sterilizers Used in Health Care Facilities; Draft Guidance for Industry and FDA Reviewers
2303CDRH Manual for the Good Guidance Practices (GGP) Regulations; Final Guidance for FDA Staff
2312Part II of the EU Guidelines to GMP: Basic Requirements for Active Substances used as Starting Materials
2313SUPPLEMENTARY GUIDELINES ON GOOD MANUFACTURING PRACTICES FOR HEATING, VENTILATION AND AIR-CONDITIONING (HVAC) SYSTEMS FOR NON-STERILE DOSAGE FORMS (October 2005)
2314FIGURES TO SUPPLEMENTARY GUIDELINES ON GOOD MANUFACTURING PRACTICES FOR HEATING, VENTILATION AND AIR-CONDITIONING (HVAC) SYSTEMS FOR NON-STERILE DOSAGE FORMS
2329Q4B Annex 1 Residue on Ignition/Sulphated Ash General Chapter Analytical Procedures and/or Acceptance Criteria (APAC)
23332005/28/EC - Commission Directive 2005/28/EC of 8 April 2005 laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products
2334EC/2743/98 - Council Regulation (EC) No 2743/98 of 14 December 1998 amending Regulation (EC) No 297/95 on fees payable to the European Agency for the Evaluation of Medicinal Products (Official Journal L 345, 19/12/1998 P. 3 - 8 CONSLEG - 95R0297 - 19/12/1998 - 15 p.).
2335EC/494/2003 - Commission Regulation (EC) No 494/2003 of 18 March 2003 amending Council Regulation (EC) No 297/95 on the fees payable to the European Agency for the Evaluation of Medicinal Products
2336EC/507/2006 - Commission Regulation (EC) No 507/2006 of 29 March 2006 on the conditional marketing authorisation for medicinal products for human use falling within the scope of Regulation (EC) No 726/2004 of the European Parliament and of the Council (Official Journal L 92, 30/3/2006 p. 6 - 9).
23372006/C 133/05 Guideline on the definition of a potential serious risk to public health in the context of Article 29(1) and (2) of Directive 2001/83/EC (Official Journal C 133, 8/6/2006 p. 5 - 7)
2349EC/1905/2005 Council Regulation (EC) No 1905/2005, of 14 November 2005, amending Regulation (EC) No 297/95 on fees payable to the European Medicines Agency (Official Journal L 340, 13/11/2005 p. 1 - 9)
2354EC/1905/2005 Council Regulation (EC) No 1905/2005, of 14 November 2005, amending Regulation (EC) No 297/95 on fees payable to the European Medicines Agency
2355EC/2049/2005 Commission Regulation (EC) No 2049/2005, of 15 December 2005, laying down, pursuant to Regulation (EC) No 726/2004 of the European Parliament and of the Council, rules regarding the payment of fees to, and the receipt of administrative assistance from, the European Medicines Agency by micro, small and medium-sized enterprises
2370Annual Reports for Approved Premarket Approval Applications (PMA)
2507MEDICINAL PRODUCTS ACT (THE DRUG LAW) - (ARZNEIMITTELGESETZ – AMG)of the FEDERAL REPUBLIC OF GERMANY
2534AIDE-MEMOIRE ON THE INSPECTION OF MEDICINAL GASES PI 025-2
2547Guidance on Parametric Release (PIC/S PI 005-3)
2560Guide to Good Manufacturing Practices of preparation of medicinal products in healthcare establishments (PIC/S PE 010-3)
2565Water for pharmaceutical use (WHO Technical Series 929)
2566Heating, ventilation and air-conditioning systems for non-sterile pharmaceutical dosage forms
2567Validation
2568Good distribution practice for pharmaceutical products
2570Medical Device Use-Safety:Incorporating Human Factors Engineering into Risk Management
2571Multisource (generic) pharmaceutical products: guidelines on registration requirements
2572Propasal to waive in vivo bioequivalence requirements for WHO Model List of Essential Medicines immediate release, solid oral dosage forms
2573Additional Guidance for organisators performing in vivo bioequivalence studies
2574Guidelines for registration of fixed-dose combination medicinal products
2583COMPLIANCE POLICY GUIDE Sec. 160.900 Prescription Drug Marketing Act - Pedigree Requirements under 21 CFR Part 203
2585GAMP Good Practice Guide Global Information Systems
2586GAMP Good Practice Guide IT Infrastructure Control and Compliance
2587GAMP Good Practice Guide Testing of GxP Systems
2588GAMP Good Practice Guide Validation of Legacy Systems
2589GAMP Good Practice Guide A Risk-based Approach to Compliant Electronic Records and Signatures
2590GAMP Good Practice Guide Validation of Laboratory Computerized Systems
2598Medical Devices Post Market Surveillance: Global Guidance for Adverse Event Reporting for Medical Devices
2599Guidelines for Regulatory Auditing of Quality Management Systems of Medical Device Manufacturers – Part 2: Regulatory Auditing Strategy
2600Principles of Medical Devices Classification
2601Principles of Conformity Assessment for Medical Devices
2602Information Document Concerning the Definition of the Term “Medical Device”
2603Medical Devices Post Market Surveillance: Content of Field Safety Notices
2604Medical Devices: Post Market Surveillance: National Competent Authority Report Exchange Criteria and Report Form
2605Review of Current Requirements on Postmarket Surveillance
2606Summary of Current Requirements for Where to Send Adverse Event Reports.
2619Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions Annex 2: Test for Extractable Volume of Parenteral Preparations General Chapter
2621The Use of Mechanical Calibration of Dissolution Apparatus 1 and 2 – Current Good Manufacturing Practice (CGMP)