PIC/S: REVISION OF PIC/S GMP GUIDE

The PIC/S GMP Guide (PE 009-8) has been revised in parallel with the EU GMP Guide. It is now available on the PIC/S website.

Updated September 2009:

http://www.picscheme.org/publication.php?id=4

The following changes were made:

Chapter 1 (Part I) has been revised in order to include aspects of quality risk management within the quality system framework.

Annex 1 has been revised in order to align the classification table for environmental cleanliness of clean rooms with ISO standards and to provide supplementary guidance on the application of the principles and guidelines of GMP to sterile medicinal products, in particular:

• Classification table for environmental cleanliness of clean rooms, and associated text;
• Guidance on media simulations;
• Guidance on bioburden monitoring;
• Guidance on capping of vials.

A new Annex 20 has been adopted in order to implement the ICH Q9 guideline on Quality Risk Management. This Annex is voluntary.

The revised PIC/S GMP Guide will enter into force on 1 March 2009 (except for provisions on capping of vialsat Annex 1 which willenter into force on 1 March 2010).