A new version of Annex 16: Certification by a Qualified Person and Batch Release has been published on EU Commission web page. Deadline for coming into operation is 15.April.2016.
Find Annex 16 under EU GMP link:
A new version of Annex 16: Certification by a Qualified Person and Batch Release has been published on EU Commission web page. Deadline for coming into operation is 15.April.2016.
Find Annex 16 under EU GMP link:
This is certainly an improvement over the previous version. This version provides better clarity and a majority of the comments provided by industry on the earlier draft have been taken into account