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How to Implement Annex 1 in the Drug Substance World - A Consensus

‐ Apr 27, 2022 8:10am

The scope of Annex 1 states that the principles and guidance within it can be applied to other non sterile products, such as low bioburden biologic intermediates. However, this scope wording has been interpreted in multiple ways by drug manufactures, for example some companies think ‘you must apply all of it’ whilst others interpret it as ‘you can apply some of it’. The BioPhorum industry collaboration has written an ‘interpretation’ paper, explaining how some of the excellent principles and guidance within Annex 1 can successfully be applied to the low bioburden Drug Substance world to improve product quality and patient safety. It also discusses the key differences between how they would be applied to sterile Drug Product manufacture. The presentation will outline those key principles, such as use of BSCs, Filter Integrity Testing, and the audience will have a better understanding of how best to utilise the Annex 1 guidance where it can be applied to low bioburden biologic intermediates It will discuss how key principles within annex 1 can successfully be applied to manufacture of low bioburden biologic intermediates to improve product quality and patient safety.


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