GMP NEWS 2002

New Initiative by FDA

New PIC/S Document PI 009-1 "Inspection of Utilities" came into force as AIDE MEMOIRE on 1 July 2002

New PIC/S Recommendation PI 014-1: "Isolators used for aseptic processing and sterility testing"

Europe's Answer to the FDA Investigational Manual

Sterility Testing: PIC/S Document PE 001-2 with Recommendations for GMP Inspectors

New Monograph on Near Infrared Spectroscopy in the USP

Draft EMEA Note for Guidance on DMF Procedures

FDA Requirements to Shipping and Storage Containers

EMEA Guideline on Water for Pharmaceutical Use Revised

List of Part-11 Suppliers in the FDA Dockets

Revision of the Directive 91/356/EEC

The PECA Agreements on GMP

Proposed Changes to the Variations Regulation - New Categories of EU Variations

Warning Letter Report: Overview of the FDA Warning Letters of the Year 2001

Quality Management System - The Experience of a Medium-sized Cosmetics Company

Web-based Training Course "A Tour of FDA"

Check List for Part-11 Systems

CTD - Transition Period Runs Out on 1 July 2003

FDA: Federal Standard 209 Replaced

New PIC/S Draft Guideline on Computer Validation

Live Online Training: Reduced Sampling - Reduced Testing

Recommended Event

17/18 June 2021

Live Online Training: Reduced Sampling - Reduced Testing

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