EDQM: CEPs for Sterile Substances
The European Directorate for the Quality of Medicines & HealthCare (EDQM) has published further guidance for the preparation of dossiers to obtain a Certificate of Suitability (CEP) for a sterile substance.
This document clarifies the conditions for acceptability of this type of dossiers and describes the documentation to be provided.
The documentation to be provided for the sterile substance concerns the following aspects:
• Justification for method of sterilisation
• Manufacturing areas
• Summary of manufacturing process related to sterile filtration/aseptic processing
• Information on filters used
• Validation of the filters used
• Sterilisation of filters and processing equipment
• Pre-filtration bioburden
• Re-use of filters
• Aseptic processing
• Process simulation/validation
• Sterilisation of packaging
• Re-test period
Source:
EDQM: Newsroom
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