GMP NEWS 2004

FDA White Paper: Innovation and Continuous Improvement in Pharmaceutical Manufacturing

FDA and EMEA Presentation on Hot GMP and Regulatory Topics

Analysis of the Changes Concerning Process Simulation in FDA's New Aseptic Processing Guide

Which Areas Are Evaluated During FDA Inspections of Laboratories?

New: ICH Q7A - Side-by-Side Comparison with APIC's How-to-Do Document

FDA's Final PAT Guidance - Which Changes Have Been Made?

New FDA Draft Guidance on cGMP for Combination Products

FDA-Meeting About Follow-on Protein Products

Risk-ranking Model for Prioritising GMP Inspections - FDA's Pilot Model

FDA Publishes 5 New Guidances

ICH Q9 "GMP Risk Management"

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"

FDA Statement on Media Failures

Extension of the Scope of Pharmacopoeia Reference Standards Planned

EU: Quality of Drug Substance in the Dossier - Revised CPMP Guidelines

New Annex 2 to Note for Guidance on Process Validation

Dissolution Testing in Human Drug CGMP Notes

New Q-and-A Website on cGMP by FDA

FDA Award to Dr Lothar Hartmann and Dr Norman Franklin!

The New FDA Strategy - The Speech of the New FDA Acting Commissioner

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