Annex 16 — QP certification and batch release
Annex 16 sets out the responsibilities of the Qualified Person in certifying that each batch was manufactured and tested in accordance with GMP and the marketing authorisation before it is released to the market.
Annex 16 sets out the responsibilities of the Qualified Person in certifying that each batch was manufactured and tested in accordance with GMP and the marketing authorisation before it is released to the market.
Plain-English explanation, then the primary regulation it comes from.
Understanding annex 16 — qp certification and batch release
The central principle is that certification is a personal responsibility of a named QP and cannot be delegated. The QP confirms compliance with GMP, with the marketing authorisation, and with any relevant technical agreement. That responsibility is personal even though the QP necessarily relies on the work of many other people.
Annex 16 addresses that reliance directly. A QP may rely on the site's quality system and on the work of others, provided that reliance has a documented basis: audits, quality agreements, defined information flows and knowledge of the sites involved. The annex sets out what the QP should be assured of when manufacture and testing occur across multiple sites, including in third countries — where the QP also confirms the equivalence of manufacturing standards for imported product.
The provisions on unexpected deviations are the ones practitioners consult most. Where a deviation occurs, the annex describes the conditions under which a batch may still be certified, requiring assessment and documented rationale. This is exactly the reasoning an inspector will ask to see, and a certified batch carrying an unresolved significant deviation with no recorded justification is a serious finding.
Certification must be recorded in a register or equivalent as each batch is certified. Operationally, the biggest risk most sites carry is structural rather than regulatory: a single QP with no trained deputy makes batch release a single point of failure for the entire supply chain.
- Personal and non-delegable
- A named QP certifies; the responsibility cannot be transferred.
- Certification vs release
- Certification is the regulatory act confirming compliance; physical release follows.
- Documented basis for reliance
- Audits, quality agreements and information flows underpin reliance on other sites.
- Imported product
- Additional assurances apply, including equivalence of manufacturing standards for third-country manufacture.
- Unexpected deviations
- Conditions under which an affected batch may be certified, with documented assessment.
- Certification register
- Each certified batch recorded in a register or equivalent document.
Common failure modes
- One QP, no deputy — release becomes a single point of failure.
- Reliance on a contract site with an out-of-date quality agreement or no current audit.
- Certifying against an open deviation with no documented rationale.
- Procedures using 'release' ambiguously, so it is unclear which act occurred and when.
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
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