GMP NEWS 2002

EU-GMP Guide Annex 1 (Sterile Medicinal Products) to Be Revised

5th European API Conference - Review

Poll on 21 CFR Part 11

New WHO Guideline on GMP-compliant Storage - "Good Storage Practices"

Wallhäußer Award for Drug Quality and Safety Given to Dr L. Huber

Systems Inspections 2002 - FDA's New Approach to Inspections

FDA's New Draft Guidance on Electronic Copies of Electronic Records

Revision of the Variations Regulation - New Proposal released on 25 October 2002 - New Categories of EU-Variations

Heidelberg - an Attractive Conference Venue with Optimal Accessibility via Frankfurt

Warning Letter Report - Data Base Publication

First Analysis of the New FDA Draft on Aseptic Processing

Part-11-Compliance CD Finished

Advanced GMP Search Function

The Rapid Alert System for the PIC/S Member Countries

Long-awaited Draft Guide on Aseptic Processing Published

FDA Slides on ICH Q7A Available

Calibration Management Guide Published by GAMP

2 Position Papers on APIs published by APIC

21 CFR 211.198 - Complaint Warning Letters in Detail

Guidances for Part 11 published by FDA on September 5, 2002

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Environmental Monitoring Data Management – from collecting to trending

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