EDQM: New guideline for sterile substances published
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In November, the new guideline 'Content of the dossier for sterile substances (PA/PH/CEP (23) 54)' was published on the EDQM (European Directorate for the Quality of Medicines & HealthCare) website. After the commenting phase ended mid of August, the final guideline is now available there.
The guideline is comprised of three chapters, with chapter 3 containing further subsections. The now finalised guideline is structured as follows:
1. Introduction
2. Scope
3. Documentation to be provided for the sterile substance
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
Take a look at the new guideline 'Content of the dossier for sterile substances (PA/PH/CEP (23) 54)' in the 'Certification Policy Documents & Guidelines' section of the EDQM website under 'Content of a dossier'.
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