Due to the increasing interest in certificates of suitability for sterile substances, the EDQM has invited CEP holders and users to a dedicated webinar on 4 June 2025. The event has shed light on the certification procedure for sterile substances (including GMP aspects) and also provided an opportunity to share difficulties encountered with interpreting EDQM guidance for sterile substances, with the preparation of CEP applications for sterile substances and with the use of these CEPs once granted.
A presentation addressing the content of a CEP dossier for a sterile substance and the inspector’s and assessor’s viewpoints was followed by a Q&A session.
Target audience
This webinar is of interest to CEP applicants, holders and users dealing with sterile substances, including manufacturers and competent authorities.
Register to watch the recording
Duration: 1 hour, 30 minutes
Download the presentations
- EU GMP Annex 1 in an API Environment, Thomas Hecker
- Sterilisation: Critical Quality Aspects – Assessor’s viewpoint, Nynke Brouwer
- Update of EDQM policy on sterile substances, Andrea Melloni
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