Alastair Coupe
Articles
A guide to EFPIA's Mock P.2 document
Gerd Fischer;Alastair Coupe;Alistar Swanson;Stephan Roenninger;Fritz Erni;Gordon Muirhead;Chris Potter;Rafæl Beerbohm;Staffan Folestad
December 1st 2006EFPIA's 'Mock P.2' document aims to show how the role of 'quality risk management' and process analytical technology as an enabler for quality by design can be presented in a common technical document format. This article summarizes the main features of this document, and explains the key concepts and principles used.
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