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PIC/S GMP Guide Revision - 11 Dec 2012

The revised PIC/S GMP Guide (PE 009-10) has been posted on their website.  Although the revisions directly concerns Chapter 4 (Documentation) and Annexes 6 (Medicinal Gases), 7 (Herbal Medicinal Products), 11 (Computerised Systems) and 13 (Investigational Medicinal Products) all parts of the document is affected by the revision. 

The PIC/S GMP guide is exactly the same as the EU GMP guide, except in some minor detail.  For instance, the EU GMP guide refers to the Qualified Person and the PIC/S Guide replaces the concept with the term ‘Authorised Person’.  The revised PIC/S GMP Guide will come into force on 1 January 2013, same time as the recent changes in the EU GMP Guide.

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