European Commission publishes revised Annex 1

摘要

GLOBAL The Directorate for Health and Food Safety of the European Commission has published a new draft for the revision of Annex 1 of the EU GMP Guide to Good Manufacturing Practice, the ECA Academy has reported. Organisations and stakeholders can submit their comments to the revised document within the three-month consultation period. The Annex 1 of the "Manufacturing of sterile medicinal products" was first published in 1971, and has been updated several times over the years. Amends have been around the classification table of cleanrooms to include guidelines on media simulation and biological stress monitoring, and the guidelines on vial sealing in 2010. The current review dates back to 2017 when the first draft of a fundamental revision was published. It was intended to focus on structured guidance, incorporating contemporary principles such as quality risk management and consideration of new technologies and innovative processes.