EDQM: Draft Guideline on ‘Content of the Dossier for Sterile Substances’
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
Meet the GMP Compliance Adviser
The GMP Compliance Adviser is the world's largest knowledge portal for quality management in the pharma business.
The demo access is non-binding and ends automatically.
You may also be Interested in the Following Articles:
