| Nr. | Date | Title |
| |
| 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 |
