EDQM: Draft Guideline on ‘Content of the Dossier for Sterile Substances’

24.05.2024

News

The European Directorate for the Quality of Medicines & HealthCare (EDQM) has drafted a guideline ‘Content of the dossier for sterile substances’ (PA/PH/CEP (23) 54). The draft document is now available for public consultation until 15 August 2024.

Certificates of Suitability (CEPs) certify compliance of an API with a monograph, but additional information is required for sterile substances. Following a policy update last year, EDQM's draft outlines the necessary submission details, starting with a justification for the sterilisation method, typically sterile filtration. If dry heat sterilisation is used, it must be "adequately" justified. The document also covers requirements for manufacturing areas, filter validation and sterilisation, aseptic processing, and other dossier details.

Source:

EDQM: Newsroom

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