Manufacturing Practices: Revisions to Europe’s cGMP Guide

BIO submitted comments on the Annex 2, Revision 2, of the European GMP Guide: Manufacture of Biological Medicinal Products for Human Use, which extends the breadth of good manufacturing practices for medicinal products for human and veterinary to include several new product types such as transgenic derived products and the Advanced Therapy Medicinal Products. While the second revision has been significantly improved over the previous draft, BIO continues to be concerned that the proposed revised Annex 2 creates an inconsistent set of requirements for biological drug substance manufacture.