{"id":285,"date":"2026-07-29T14:56:04","date_gmt":"2026-07-29T12:56:04","guid":{"rendered":"https:\/\/www.pqra.gr\/the-qualified-person-and-batch-release-the-last-line-of-defence\/"},"modified":"2026-07-29T14:56:23","modified_gmt":"2026-07-29T12:56:23","slug":"the-qualified-person-and-batch-release-the-last-line-of-defence","status":"publish","type":"post","link":"https:\/\/www.pqra.gr\/el\/the-qualified-person-and-batch-release-the-last-line-of-defence\/","title":{"rendered":"The Qualified Person and Batch Release: The Last Line of Defence"},"content":{"rendered":"

No medicinal product can be placed on the EU market until a Qualified Person (QP) has certified the batch. It is one of the most consequential signatures in the pharmaceutical industry — a personal, legal responsibility that no company procedure can override. Understanding what the QP certifies, and what they need in order to do so, is fundamental to a functioning quality system.<\/strong><\/p>\n\n

A legal role, not just a job title<\/h2>\n

The role of the QP is established in EU law. Article 51 of Directive 2001\/83\/EC requires that every batch of a medicinal product be certified by a QP before release, confirming that it has been manufactured and checked in accordance with the marketing authorisation and with good manufacturing practice. The QP must meet defined qualification and experience criteria and is named on the manufacturing or import authorisation. The responsibility is personal: the QP certifies in their own name.<\/p>\n\n

What Annex 16 requires<\/h2>\n

Annex 16 of the EU GMP Guide sets out how certification and batch release work in practice. Before certifying, the QP must be satisfied that a range of conditions has been met, including:<\/p>\n