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GMP News Overview 2001

15517.12.2001Preview of Standards for Cleanroom Technology
15313.12.2001Validation of Analytical Methods: Intermediate Precision
15212.12.2001Quality System Inspection Technique
15108.12.2001New Version of Compilation of Community Procedures on Inspections and Exchange of Information
14615.11.2001Professional Certification Programme
14412.11.2001GMP Deficiencies in Europe
14309.11.2001Essentials of the 4th CEFIC/APIC European Conference on Active Pharmaceutical Ingredients
13910.10.2001Acceptance of Near Infrared Spectroscopy (NIRS) by the Regulatory Authorities
14009.10.2001FDA Draft Guidance for 21 CFR Part 11
13501.10.2001New Books on Pharmaceutical Quality Assurance
13213.09.2001Help with Electronic Records and Electronic Signatures
13112.09.2001New Draft Recommendation on Isolators Used for Aseptic Processing and Sterility Testing
12821.08.2001Measurement Uncertainty
12720.08.2001Annex 1 gendert
12125.07.2001ICH Guideline Published as Annex to the EU Guide to Good Manufacturing Practice, Eudralex Volume 4
12024.07.2001Current Trends in FDA Warning Letters
11919.07.20014 New Annexes to EC GMP Guideline Finalised
11509.07.2001New Books on Pharmaceutical Automation
11402.07.2001New requirements for pharmaceutical water in Europe
11330.06.2001New FDA inspection system
11226.06.2001Zwei neue Bcher von Dr. Michael Jahnke: Mikrobiologisches und Umgebungsmonitoring bei der Media Fill Validierung
10606.04.2001HACCP - getting closer and closer
10503.04.2001News from the USA: BACPAC I now approved
10402.04.2001FDA-Drug Manufacturing Inspections (Pilot Program)
10002.04.2001CD-ROM GMP Navigator 3.0 just released!
9801.03.2001Third Party Audit as a Part of Shared Audits
9701.03.2001Final Draft of Annex 15 published!
9326.02.2001ECA continues its success in 2000
9106.02.2001New European Pharmacopoeia specifications for the system suitability test and for the delimitation between adjustment and modification of a method
9006.02.2001Annex 15 coming.....Annex 15 coming....
8919.01.2001PIC/S Committee Meeting on 24 October 2000

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