EU GMP Annex 16 - Certification by a Qualified Person and Batch Release

What it says

A named Qualified Person must personally certify each batch of medicinal product before release to the market, confirming the batch was manufactured and checked in accordance with the marketing authorisation and applicable GMP requirements, with the certification act itself being personal and non-delegable, carrying statutory legal liability.

Paraphrased for plain-language clarity. Always verify against the current published regulation text.

What it means in practice

• The Qualified Person's certification is a distinct legal act, not simply a quality sign-off - it carries personal statutory liability that continues even after the certification is complete, including notification obligations if a significant quality defect is later discovered.
• Certification confirms compliance with the specific marketing authorisation as filed, meaning any deviation from the approved process, even one that does not affect product quality, is a certification-relevant issue requiring assessment.
• While preparatory review activities supporting certification can be delegated, the certification act itself cannot be delegated to anyone other than the named Qualified Person.

What inspectors look for

• Whether the Qualified Person's certification decision is based on genuine, complete review of the batch evidence package, not a rubber-stamp approval of a pre-assembled conclusion.
• Whether any known deviation from the marketing authorisation, however minor it may seem, was assessed as part of the certification decision.
• Whether the site has a clear, documented process for what happens if a Qualified Person identifies a concern that would prevent certification.

Related regulations