Batch release
Batch release is the decision that a batch may be placed on the market; in the EU each batch must be certified by a Qualified Person who confirms it was made and checked in accordance with GMP and the marketing authorisation.
Batch release is the decision that a batch may be placed on the market; in the EU each batch must be certified by a Qualified Person who confirms it was made and checked in accordance with GMP and the marketing authorisation.
Plain-English explanation, then the primary regulation it comes from.
Understanding batch release
Annex 16 governs certification, and the QP's responsibility is personal and cannot be delegated. The QP confirms that the batch was manufactured and tested in accordance with GMP, the marketing authorisation and any relevant agreement. Certification is the regulatory act; physical release to saleable stock is the subsequent logistical step, and conflating the two causes real confusion in procedures.
The QP relies on others, and Annex 16 accepts this — but the reliance has to be structured. Where parts of manufacture or testing occur elsewhere, the QP needs assurance through audits, quality agreements and defined information flows. 'The contract site said it was fine' is not assurance; a documented basis for relying on the contract site is.
Where a batch has an unresolved deviation, the QP decides whether it can still be certified, and that decision must be documented with its rationale. Annex 16 addresses handling of unexpected deviations, and the reasoning is precisely what an inspector will ask to see. A certified batch with an open critical deviation and no recorded rationale is a serious finding.
Operationally, release time is rarely lost where sites assume. Mapping the path end to end usually shows batches waiting on documentation review, on open deviations, or on one QP as the single point of decision — not on analysis. Rebuilding review so low-risk batches move without weakening the decision on the ones that matter is where the days come back.
- QP certification is personal
- The named QP takes the decision and it cannot be delegated.
- Certification ≠ physical release
- Certification is the regulatory act; release to saleable stock follows it.
- Reliance must be structured
- Audits, quality agreements and defined information flows underpin reliance on other sites.
- Unexpected deviations
- Annex 16 sets expectations for certifying a batch affected by a deviation, with documented rationale.
- Register of certification
- Certification is recorded in a register or equivalent as each batch is certified.
Common failure modes
- Procedures that use 'release' for both certification and physical release, so responsibilities blur.
- A single QP with no trained deputy, making release the site's structural bottleneck.
- Certifying against an open deviation without recording the rationale.
- Reliance on a contract site with no current audit and an out-of-date quality agreement.
Where this is written down
- European CommissionEudraLex Volume 4 — EU GMP guidelines
Annex 16 — Certification by a Qualified Person and Batch Release
- EMAEMA — Good manufacturing practice
EMA guidance on QP responsibilities and importation
Read next
Annex 16 — QP certification and batch release
ReadQualitySupplier qualification
ReadQualityDeviations
ReadQualityComplaints and recalls
ReadLooking for a definition rather than an explanation? The GMP glossary covers the abbreviations in one line each.
Knowing the requirement is not the same as closing the gap
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