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Reply To: Seeking examples of finished product release documentsApril 27, 2023 at 8:53 am
We do not have an ERP yet and our team only signs off on the manufacturing batch record but does not issue a separate certificate of release. So, we don’t have anything with to verify against to load into IRT or to control distribution and we have already had a few deviations for shipping into wrong places or with wrong drug. We are asking for the non-EU team to give us a document with those details as you said but they have no experience doing this and say it is for supply chain alone to fix.