EDQM: New Guideline for sterile Substances published for Comment

The draft of the new guideline "Content of the dossier for sterile substances" (PA/PH/CEP (23) 54, draft 4) is now available for comments on the EDQM (European Directorate for the Quality of Medicines & HealthCare) website. Remarks and comments can be submitted until 15 August 2024.

The guideline consists of three chapters, with chapter 3 containing further subsections. The document is organised 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

On the EDQM website go to the section "Consultation space" to find and comment on the draft of the Guideline "Content of the dossier for sterile substances" (PA/PH/CEP (23) 54, draft 4).