EDQM: New guideline for sterile substances published

The EU Pharmaceutical Legislation Reform: Impact on the API Industry

Recommendation

21 October 2025
Barcelona, Spain

The EU Pharmaceutical Legislation Reform: Impact on the API Industry
An ECA Course prior to the 28th APIC/CEFIC Global GMP & Regulatory API Conference

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'.