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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)
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