The Qualified Person and Batch Release: The Last Line of Defence

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.

A legal role, not just a job title

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.

What Annex 16 requires

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:

• manufacture and testing in line with the marketing authorisation and GMP;
• the whole supply chain of active substance and finished product being auditable and compliant;
• completion of the batch record, including deviations, investigations and change controls;
• for imported products, appropriate arrangements for testing and, where relevant, mutual-recognition agreements.

The QP must have access to all the information needed to make the decision; nothing relevant may be withheld.

Handling deviations

Real manufacturing rarely runs perfectly. Annex 16 explicitly addresses unexpected deviations: a batch affected by a deviation may still be certified if a documented risk assessment demonstrates that the impact on quality, safety and efficacy is negligible, and the deviation is properly investigated and closed. This is where the QP’s judgement matters most — and where inadequate investigation records most often block release.

Building a reliable release process

• Ensure the QP is engaged in the quality system continuously, not merely at the point of signature.
• Maintain complete, contemporaneous batch documentation so certification is not delayed by missing records.
• Have a clear, GMP-compliant procedure for managing and escalating deviations.
• For imported or contract-manufactured products, confirm responsibilities and technical agreements are watertight before the first batch.

How PQRA helps

PQRA supports manufacturers and marketing-authorisation holders in building robust batch-release processes — from QP arrangements and technical agreements to deviation management and the documentation that certification depends on. We help ensure that when the QP signs, the evidence behind that signature is complete and defensible.

Contact PQRA to strengthen your batch-release and QP arrangements.