Thursday, 15 October 2015

EU GMP Annex 16 - revised


EU GMP Annex 16: Certification by a Qualified Person and Batch Release

Information via the Pharmaceutical and Healthcare Sciences Society:

The Annex has been revised to reflect the globalisation of the pharmaceutical supply chains and the introduction of new quality control strategies. The revision has been carried out in the light of Directive 2011/62/EU amending Directive 2001/83/EC as regards the prevention of the entry into the legal supply chain of falsified medicinal products. This version also implements ICH Q8, Q9 and Q10 documents, and interpretation documents, such as the manufacturing and importation authorisation (MIA) interpretation document, as applicable. Also, some areas, where the interpretation by Member States has not been consistent, have been clarified.

For further details see EU GMP

Posted by Tim Sandle

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