Current Edition

Annex 1-Implementation of the Final Draft

Annex 1 “Manufacture of Sterile Medicinal Products” was first published in 1971 and forms part of EudraLex Volume 4 [1], which interprets the basic principles of GMP as detailed in European Directive 2003/94/ EEC [2]. Annex 1 provides guidance on the minimum controls that are required to protect sterile medicinal products during manufacturing. Patrick Nieuwenhuizen, Director Senior Consultant at PharmaLex gives a brief overview of the new Annex 1. The overall message for manufacturers of sterile products is to ensure the systems and processes are in place to demonstrate sustainable control of the entire process and associated facilities, therewith ensuring product safety and ultimate protection of the patient.