Certification by a Qualified Person and Batch Release
EU GMP Annex 16 sets out the responsibilities of the Qualified Person (QP) in certifying that each batch of a medicinal product complies with its marketing authorisation and with good manufacturing practice before release to the EU or EEA market. Part of EudraLex Volume 4, the revised annex came into operation on 15 April 2016. It describes how a QP may rely on a chain of certification and confirmation across multiple sites and other QPs, how unexpected deviations are handled, and the QP's continuing duty to assess the supply chain. It also covers sampling, importation, and the personal, non-delegable nature of certification.
What this does not cover
stated in the document's own scope- It does not itself define the importation controls for finished product, which are detailed in EU GMP Annex 21.
- It does not cover qualification and validation activities; those are the subject of EU GMP Annex 15.
- It does not set the requirements for investigational medicinal products, whose QP certification follows the IMP GMP framework.
- It describes the certification decision, not the technical GMP for specific dosage forms, which sits elsewhere in the guide and its annexes.
Always verify against the current published text before relying on it for a submission or inspection.
Overview
EU GMP Annex 16 governs the final gate before a medicine reaches European patients: certification by a Qualified Person. The QP is a legally named individual who confirms, batch by batch, that the product was made and tested in accordance with its marketing authorisation and with GMP. The revised annex, in operation since April 2016, reflects modern multi-site supply chains: it explains how one QP may rely on the confirmations of others across a chain of certification, what to do when an unexpected deviation arises, and how imported product must be handled. Certification remains a personal responsibility that cannot be delegated away.
Legal basis & how it acquires force
Annex 16 is part of EudraLex Volume 4, the EU GMP guide. It elaborates the QP certification duty set in the medicines Directives 2001/83/EC for human products and 2001/82/EC for veterinary products and the manufacturing-authorisation requirements they impose. The guide acquires force because holding a manufacturing and importation authorisation obliges the site to comply with EU GMP; national competent authorities enforce it through inspection. The QP's role and obligations are a legal condition of that authorisation, not merely guidance.
Document structure
| Part | Covers |
|---|---|
| The process of certification | The QP's confirmation that each batch complies with the marketing authorisation and GMP, and the chain of certification across sites |
| Reliance on others | How a certifying QP may rely on confirmations from other QPs and parties, and the responsibilities that must be defined |
| Handling of unexpected deviations | Conditions under which a batch may be certified despite an unexpected deviation |
| Release of a batch | The distinction between certification and physical release, and record-keeping of the decision |
| Assessment of the supply chain | Sampling, importation, and continuous assessment of the supply chain, including active substances |
Key requirements
- Ensure a Qualified Person personally certifies each batch before release, confirming compliance with the marketing authorisation and GMP.
- Verify the full chain of manufacture, testing, and certification, relying on confirmations from other parties only where responsibilities are defined.
- Confirm that manufacturing and testing sites hold the appropriate authorisations and operate to EU or equivalent GMP.
- Assess unexpected deviations and permit certification only where the batch still complies with the marketing authorisation and registered specifications.
- Ensure imported batches are subject to the required sampling and testing within the EU or EEA, unless a mutual-recognition arrangement applies.
- Maintain continuous knowledge of the supply chain, including active-substance sourcing and audit status.
- Record each certification so the release decision is traceable to the responsible QP.
Implementation tips
- Map every site in the chain to a named responsibility, so the certifying QP knows exactly what each confirmation covers.
- Define in advance which deviation categories a QP may assess for release, and tie them to the registered specifications.
- Keep the supply-chain audit programme current, since certification relies on it being demonstrably up to date.
- Document the reasoning for certifying against an unexpected deviation at the time, not retrospectively.
International alignment
Annex 16 applies across the EU and EEA and is recognised by partner authorities through mutual-recognition agreements, which can waive re-testing of imported batches. It operates alongside Annex 21 on importation of medicinal products and Annex 15 on qualification and validation, and it depends on the pharmaceutical quality system described in ICH Q10 and in Part I of the GMP guide. Non-EU manufacturers exporting to Europe must supply the information a QP needs to certify.
EU GMP Annex 16: frequently asked questions
Quick answers to common questions about EU GMP Annex 16.
When did the revised Annex 16 take effect?
The revised EU GMP Annex 16 came into operation on 15 April 2016.
Can a Qualified Person delegate certification?
No. Certification of a batch is the personal responsibility of the QP, though the QP may rely on defined confirmations from others within a chain of certification.
Can a batch be released despite a deviation?
A QP may certify a batch affected by an unexpected deviation only if an assessment confirms the batch still complies with the marketing authorisation and registered specifications.
Does Annex 16 require re-testing of imported batches?
Imported batches generally require sampling and testing within the EU or EEA, unless a mutual-recognition agreement with the exporting country waives it.