PIC/S PE 009-16 update, part 2: New Annex 16 vs Release For Supply

PIC/S PE 009-16 update, part 2: New Annex 16 vs Release For Supply

This is the second of a two-part blog covering the changes to PIC/S version 16. Previously we discussed changes to Annex 13 – Manufacture of Investigative Medicinal Products, and today I am doing a comparison of the new Annex 16 – Certification by the Authorised Person and Batch Release and comparing it against the TGA’s…