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The process of assessing a batch against release criteria and authorising it for distribution. In the EU, QP certification is required for release.
QC testing and QP certification (EU) or authorised person release (US) must be completed before the batch is released to the market.
EU GMP Ch 5, 21 CFR 211.165
Releasing before all tests are complete or before QP certification. Inadequate investigation of OOS.
Show your batch release procedure and how you handle OOS and deviations.