In October, a 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. Annex 16 was last published in 2001, so this version has significant improvements.
The deadline for compliance with this version of Annex 16 is 15-APR-2016.
This version 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 uncertified batches of medicinal products are not transferred to saleable stock.
Not sure how to interpret the changes in this regulation? Talk to our CSV experts about how it may affect project.