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GMP News Overview 2002

27317.12.2002EU-GMP Guide Annex 1 (Sterile Medicinal Products) to Be Revised
26911.12.20025th European API Conference - Review
26804.12.2002Poll on 21 CFR Part 11
26703.12.2002New WHO Guideline on GMP-compliant Storage - "Good Storage Practices"
26602.12.2002Wallhäußer Award for Drug Quality and Safety Given to Dr L. Huber
26214.11.2002Systems Inspections 2002 - FDA's New Approach to Inspections
26113.11.2002FDA's New Draft Guidance on Electronic Copies of Electronic Records
25806.11.2002Revision of the Variations Regulation - New Proposal released on 25 October 2002 - New Categories of EU-Variations
25630.10.2002Heidelberg - an Attractive Conference Venue with Optimal Accessibility via Frankfurt
25129.10.2002Warning Letter Report - Data Base Publication
25528.10.2002First Analysis of the New FDA Draft on Aseptic Processing
25325.10.2002Part-11-Compliance CD Finished
24916.10.2002Advanced GMP Search Function
24815.10.2002The Rapid Alert System for the PIC/S Member Countries
24530.09.2002Long-awaited Draft Guide on Aseptic Processing Published
24327.09.2002FDA Slides on ICH Q7A Available
24226.09.2002Calibration Management Guide Published by GAMP
24125.09.20022 Position Papers on APIs published by APIC
24024.09.200221 CFR 211.198 - Complaint Warning Letters in Detail
23517.09.2002Guidances for Part 11 published by FDA on September 5, 2002
23204.09.2002New Initiative by FDA
22928.08.2002New PIC/S Document PI 009-1 "Inspection of Utilities" came into force as AIDE MEMOIRE on 1 July 2002
22827.08.2002New PIC/S Recommendation PI 014-1: "Isolators used for aseptic processing and sterility testing"
22727.08.2002Europe's Answer to the FDA Investigational Manual
22626.08.2002Sterility Testing: PIC/S Document PE 001-2 with Recommendations for GMP Inspectors
22524.08.2002New Monograph on Near Infrared Spectroscopy in the USP
22423.08.2002Draft EMEA Note for Guidance on DMF Procedures
21805.08.2002FDA Requirements to Shipping and Storage Containers
21703.08.2002EMEA Guideline on Water for Pharmaceutical Use Revised
21602.08.2002List of Part-11 Suppliers in the FDA Dockets
21103.07.2002Revision of the Directive 91/356/EEC
21002.07.2002The PECA Agreements on GMP
20901.07.2002Proposed Changes to the Variations Regulation - New Categories of EU Variations
20518.06.2002Warning Letter Report: Overview of the FDA Warning Letters of the Year 2001
19924.05.2002Quality Management System - The Experience of a Medium-sized Cosmetics Company
20123.05.2002Web-based Training Course "A Tour of FDA"
20022.05.2002Check List for Part-11 Systems
19307.05.2002CTD - Transition Period Runs Out on 1 July 2003
19203.05.2002FDA: Federal Standard 209 Replaced
18811.04.2002New PIC/S Draft Guideline on Computer Validation
18708.04.2002FDA-compliant Seal Materials in the Endurance Test
18605.04.2002GMP in Biotechnology
18504.04.2002New FDA Guidance on 21 Cfr Part 11 - »Time Stamps«
18403.04.2002New ICH Guidelines on Stability Testing
17708.03.2002New Draft of Annex 13 - Manufacture of Investigational Medicinal Products
17602.03.2002Do You Already Know the PIC/S Document PI 006-1?
17428.02.2002Revision of the IPEC 'GMP Guide for Bulk Pharmaceutical Excipients' - An important contribution towards drug safety
17328.02.2002On 1 February 2002 the FDA System-based Inspections Came into Force
17528.02.2002Amendment to a European Directive Concerning Traditional Herbal Medicinal Products
17227.02.2002What now, MRA?
19817.02.2002Annual Review 2001
16528.01.2002Revision of the Note for Guidance on Chemistry of the New Active Substance
16009.01.2002New Draft for a CPMP Guideline on Near Infrared Spectroscopy: NIRS in the Dossier for a Marketing Authorisation
15908.01.2002"Note for Guidance on Quality of Water for Pharmaceutical Use"

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