Annex 1 Applied in Drug Substance Facilities
This workstream is developing an industry consensus interpretation of how to apply the new Annex 1 guidance to drug substance facilities.
The potential scope extension and the tendency to overinterpret guidance
Updated EU regulatory guidance for sterile drug products was published in August 2022 and came into operation in August 2023. The scope has been updated and the guidance can now be applied for other products that are not intended to be sterile, e.g. low bioburden biological intermediates.
It is anticipated that there will be a regulatory expectation that compliance will be required with some aspects of Annex 1 in drug substance facilities. Individual companies may be inclined to overinterpret the guidance, resulting in unnecessary expense, and influencing agencies to set even higher requirements, which may not improve patient safety.
Defining an industry consensus approach to interpreting Annex 1 for the benefit of all in low bioburden biologic drug substance manufacturing
This workstream is working towards defining an industry consensus approach to applying Annex 1 to ensure an appropriate level of compliance to avoid regulatory findings, while not utilizing excessive resources for over compliance. Identifying and using positive aspects of Annex 1 will ultimately improve the quality of product and patient safety.
Annex 1 Applied in Drug Substance Facilities deliverables
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