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.
Posted by Tim Sandle
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