[Neil Armstrong]

Reply To: Seeking examples of finished product release documents

As with all GMP documentation, the content should be consise and have redundant entries or actions removed. While detailing the release countries is not typically required outside the EU, the batch release cert can be mirrored off Appendix II in EudraLEex, Annex 16: Certification by a Qualified Person and Batch Release, with added particulars to help traceability of labelled FG and maintaining records. A common template for QA batch release would detail:

The sponsor’s name (if applicable in your scenario)
The sponsor’s Clinical Trial identifier (IND is suitable for non-investigative product if applicable in your scenario)
Product name
Batch number
Batch size
Expiry date
Manufacturing date
Storage conditions
Manufacturer’s name and address
Reported deviations and status
Release statement (GMP compliance)

If your company’s ERP used for batch release does not accommodate selecting individual countries, it is worth considering the value of adding that information to the release cert and assess against risk within the company’s distribution process. The cert is not typically updated after creation. If there is a requirement to capture new approvals/country release, a new document, in my experience, is the usual practice.