BioPhorum workstreams are facilitating discussions among industry leaders about the challenges they face with Annex 1, along with those that are held to Annex 2 requirements.
The Annex will be updated to reflect current best practices and new technologies for the manufacture of sterile medicinal products. It also places a greater emphasis on the use of quality risk management (QRM) and encourages the use of QRM throughout the manufacturing process to ensure that potential risks are identified and mitigated.
Annex 1 in Drug Substance facilities
Most biologic products are ultimately sterile products, and Annex 1 is about the manufacture of sterile medicinal products. However, it also states that the guidance pertaining to sterile manufacturing operations and products could also be applied to low bioburden manufacturing facilities.
To address this, BioPhorum has been running Annex 1 Applied in Drug Substance, a workstream dedicated to applying Annex 1 to the biological (low bioburden) drug substance manufacturing facilities which are governed by Annex 2 – manufacture of biological active substances and medicinal products for human use.
The workstream is planning a series of documents on how to apply the new Annex 1 guidance to DS facilities which will be available during 2023
Fill Finish Annex 1 workstream will addressing the practicalities of implementation of the updated Annex 1. This activity will give the opportunity to share know-how and experiences and benchmark on the day-to-day challenges of implementation.
Annex 1 interest form
Sign up form for the Annex 1 specific E-Mail list.