EMA: GMP Documentation for the Sterilisation of an API
The EMA Q&A on the quality of medicines has been updated with a new question: “What kind of GMP documentation is required for an API manufacturer performing sterilisation of an active substance?”
EMA answers that the GMP requirements for active substances used as starting materials (EU GMP Guide Part II for human medicinal products or Commission Implementing Regulation (EU) 2025/2154 for veterinary medicinal products) apply only up to the point immediately before the active substance is sterilised. Sterilisation and subsequent aseptic processing are not covered and must instead comply with the GMP requirements for medicinal products, including Annex 1 of the EU GMP Guide (Part I) or Commission Implementing Regulation (EU) 2025/2091.
Consequently, active substance manufacturers performing sterilisation and subsequent aseptic handling must hold a valid manufacturing authorisation or GMP certificate issued by an EEA authority or by authorities from countries with mutual recognition arrangements.
In addition, manufacturers must provide the marketing authorisation applicant or holder with data on the sterilisation process, including validation data, for inclusion in the finished product dossier.
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