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GMP News Overview 2004

49629.11.2004FDA White Paper: Innovation and Continuous Improvement in Pharmaceutical Manufacturing
48810.11.2004FDA and EMEA Presentation on Hot GMP and Regulatory Topics
48726.10.2004Analysis of the Changes Concerning Process Simulation in FDA's New Aseptic Processing Guide
48625.10.2004Which Areas Are Evaluated During FDA Inspections of Laboratories?
48522.10.2004New: ICH Q7A - Side-by-Side Comparison with APIC's How-to-Do Document
48115.10.2004FDA's Final PAT Guidance - Which Changes Have Been Made?
48015.10.2004New FDA Draft Guidance on cGMP for Combination Products
47914.10.2004FDA-Meeting About Follow-on Protein Products
47305.10.2004Risk-ranking Model for Prioritising GMP Inspections - FDA's Pilot Model
47530.09.2004FDA Publishes 5 New Guidances
47229.09.2004ICH Q9 "GMP Risk Management"
47029.09.2004FDA'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"
46313.09.2004FDA Statement on Media Failures
46110.09.2004Extension of the Scope of Pharmacopoeia Reference Standards Planned
46209.09.2004EU: Quality of Drug Substance in the Dossier - Revised CPMP Guidelines
45424.08.2004New Annex 2 to Note for Guidance on Process Validation
45523.08.2004Dissolution Testing in Human Drug CGMP Notes
44706.08.2004New Q-and-A Website on cGMP by FDA
44304.08.2004FDA Award to Dr Lothar Hartmann and Dr Norman Franklin!
44503.08.2004The New FDA Strategy - The Speech of the New FDA Acting Commissioner
44402.08.2004New CPMP Guideline on Impurities in Pharmacopoeial Substances
43821.07.2004Draft for a New Annex 19 to the EU GMP Guide Published
43616.07.2004Inspection Findings Regarding Change Control in Production and Engineering
43515.07.2004EMEA Road Map: Information on Future GMP and GCP Inspections
43201.07.2004FDA Warning Letter Report
43130.06.2004New CPMP Guideline on Plastic Primary Packaging Materials
42718.06.2004FDA Inspection Findings Regarding Manufacturing Equipment
42427.05.2004New FDA Draft Guidances on "Chemistry, Manufacturing, and Control Information (CMC)"
42226.05.2004Latest News on MRA Agreements
42024.05.2004Epilogue 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)
41907.05.2004Good Distribution Practice and Cold Chain Management – Current Regulatory Initiatives
41806.05.2004Computer Validation: Frequently Asked Questions on GMP/FDA Compliance
41705.05.2004EU Publishes the New EU Directive 2004/27 - Consequences for the GMP-regulated Environment
41322.04.2004Public Meeting on Electronic Records; Electronic Signatures (Part 11), 11 June 2004, Washington D.C.
41122.04.2004New FDA Initiative on Process Validation
40819.04.2004Top Ten of 483 Findings by the FDA in Fiscal Year 2003
40719.04.2004FDA Presentation on Risk Management in Drug Quality
40916.04.2004FDA Has Published Additional HUMAN DRUG CGMP NOTES
40306.04.2004Deviations Regarding Documentation in FDA Warning Letters
40205.04.2004GHTF Guideline on Process Validation
40131.03.2004Revision of Directive 2001/83/EC - Consequences for the API Industry
39712.03.2004New Guideline by the Global Harmonization Task Force (GHTF) on Risk Analysis
39611.03.2004What Does an Inspector Expect of GMP Training and of a GMP Training System?
39123.02.2004GMP/FDA Requirements on HPLC Systems in the Lab
39023.02.2004New FDA Requirements on Filter Validation
38612.02.2004New Requirements on the Validation of Sterility Tests
38511.02.2004New Variations Regulations 1084/2003 and 1085/2003
37210.02.2004The New GAMP Good Practice Guide "Validation of Process Control Systems" (VPCS)
38409.02.2004Annual Review 2003
38305.02.2004New Guidelines and Regulations for the Blood-Processing Industry 
38204.02.2004Evaluation of Warning Letters Concerning Water Systems, Pipes, Dead Legs, and Valves
38103.02.2004New: Addition to the EU GMP Guide

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