Eudralex V4 Annex 16: Certification by a Qualified Person and Batch Release, 10/15

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In October, 2015, the European Commission published a new version of Annex 16, Certification by a Qualified Person and Batch Release, for EudraLex Volume 4, EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use.

The new version of Annex 16 was published due to significant changes in the globalization of pharmaceutical supply chains and the introduction of new quality control strategies since annex was last published in 2001. This version also implements ICH Q8, Q9 and Q10 documents, and interpretation documents, such as the manufacturing and importation authorization (MIA) interpretation document.

Annex 16 now specifically allows for the use of validated computerized systems as safeguards to ensure that un-certified batches of medicinal products are not transferred to saleable stock.

The deadline for compliance with this version of Annex 16 is 15-APR-2016.