PIC/S issues Update of GMP Guide

On 11 December 2012 the PIC/S posted the revised documents on their website. All parts are affected by the revision. With regard to content, though, only the introduction (update of the document history), Part I with GMPs for the manufacture of medicinal products (Chapter 4, Documentation) as well as the Annexes 6 (Medicinal Gases), 7 (Herbal Medicinal Products), 11 (Computerised Systems) and 13 (IMPs) were updated.

The content of the PIC/S GMP Guide corresponds with the EU GMP Guide - apart from a few exceptions. For instance, the EU Guide refers to the Qualified Person whereas the PIC/S Guide uses the term "Authorised Person". The revisions in the PIC/S Guide correspond with the recent changes in the EU GMP Guide. Both become effective on 1 January 2013.

You can find the PIC/S documents in the guideline database in the ECA website's members' area as well as on the PIC/S Website.