PIC/S SMF Guide Updated with Quality Management System Requirements

With the publication of ICH Q9 "Quality Risk Management" and its transferral as Annex 20 to the EU GMP Guide, the idea of using risk management as a company-wide system is increasing continuously. The same counts for ICH Q10 "Pharmaceutical Quality System" and its current implementation into chapter 1 of the EU GMP Guide.

The Pharmaceutical Inspection Cooperation Scheme (PIC/S) Committee is pulling in the same direction and has adopted the revision of the Explanatory Notes for Industry on the Preparation of a Site Master File (PE 008-4) at its meeting in Kuala Lumpur (8-9 November 2010. The main purposes of the revision were the simplification of the document and the implementation of requirements in relation with Quality Management Systems (QMS), with a focus on Quality Risk Management (QRM) and Supplier Management.

Also the release procedures of finished products and especially the role of a Authorised Person/ Qualified Person are now described.

The revised document came now into force on 1 January 2011.

A detailed evaluation of the new document and a step-by-step comparison with the EU requirements will soon be published in this newsletter.

Wolfgang Schmitt
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)