Guide to Good Manufacturing Practice for Medicinal Products Part I - PIC/S, PE 009-8 (Part I), 15 January 2009
(2009; 43 pages)

Abstract

This guide contains basic requirements for good manufacturing practice for medicinal products. The holder of a manufacturing authorisation must manufacture medicinal products so as to ensure that they are fit for their intended use, comply with the requirements of the Marketing Authorisation and do not place patients at risk due to inadequate safety, quality or efficacy.

 
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