Role of the Qualified Person (QP) in EU GMP

In short: For EU medicinal products, the Qualified Person (QP) certifies each finished-product batch before it is released for sale, supply or export. The QP bases that certification on evidence that the batch meets applicable GMP, national law and its marketing authorisation.

This article focuses on human medicines governed by Directive 2001/83/EC. The QP’s statutory duties are set out in Article 51 and are explained in the European Commission’s EudraLex Volume 4, Annex 16: Certification by a Qualified Person and Batch Release (Revision 1, 2015; effective 15 April 2016). The European Medicines Agency’s pre-authorisation guidance also explains batch certification and import arrangements under Article 51 (question 3.3.2, revised March 2024).

What the QP does

A QP provides an independent batch-certification decision within the EU manufacturing-authorisation system. Under EudraLex Volume 4, Part I, Annex 16 §§1.1 and 1.4 (Revision 1, 2015), each finished-product batch must be certified by a QP in the EU before release for sale or supply in the EU or for export, and each EU manufacturing site must have at least one QP. The EMA’s pre-authorisation guidance, question 3.3.2 (revision March 2024), confirms that each batch of a human medicinal product needs QP certification before release to the EEA market.

For a batch manufactured in the EU, the QP must establish that it was manufactured and checked in accordance with GMP, the marketing authorisation and the laws in force where certification takes place (EudraLex Volume 4, Part I, Annex 16, “General principles,” Revision 1, 2015). Certification is the quality-release decision; transfer to saleable stock is a subsequent step and must follow the authorised arrangements.

Evidence considered before certification

The QP should have access to the records and quality-system evidence needed to support the decision. Annex 16 §§1.6–1.7.21 (Revision 1, 2015) covers the checks the QP must personally ensure and the wider assurance tasks that support certification. In practice, the QP reviews evidence that:

• the manufacturing authorisation permits the certification and any additional national duties are met;
• manufacturing, testing and the supply chain are documented and consistent with the marketing authorisation;
• audits of relevant sites are complete and their reports are available;
• materials, equipment, processes and computerised systems are suitably controlled, and required validation remains current;
• batch records and in-process checks are complete, and the finished-product test results meet the approved specification;
• changes, deviations, investigations, complaints or recalls have been assessed for their effect on the batch; and
• technical agreements and distribution arrangements are in place where required.

This is a practical summary of the checks described in EudraLex Volume 4, Part I, Annex 16 §§1.7.1–1.7.21 (Revision 1, 2015). The specific evidence depends on the product, the authorised process and the batch’s manufacturing and testing history.

Imported batches and shared responsibilities

For medicinal products imported from outside the EEA, the QP applies the import testing and certification requirements of Directive 2001/83/EC Article 51(1)(b), subject to the applicable agreement under Article 51(2). The EMA states that EEA batch testing is generally required on import unless an applicable Mutual Recognition Agreement or other relevant agreement allows reliance on controls performed in the exporting country; such an agreement does not remove the need for EEA batch certification (EMA Pre-authorisation guidance, question 3.3.2.2, revised March 2024).

More than one QP may contribute to the certification of a batch. If responsibilities are shared, EudraLex Volume 4, Part I, Annex 16 §§1.4.2–1.4.3 (Revision 1, 2015) says the division must be set out in a document formally agreed by the parties, including how deviations are assessed against GMP and the marketing authorisation.

Delegation and certification records

The QP must personally ensure that certification is permitted under the manufacturing and import authorisation, that national duties are met, and that the certification is recorded. Other assurance tasks may be delegated to appropriately trained staff or third parties, but the QP must have continuing confidence in the quality system and the evidence supporting the batch (EudraLex Volume 4, Part I, Annex 16 §§1.6–1.7, Revision 1, 2015). Certification itself is made by a QP.

The QP records certification in a register or equivalent document. The entry must show that the batch satisfies the applicable requirements and remain available to the competent authority for the period set by Member State law, and in any event for at least five years (EudraLex Volume 4, Part I, Annex 16 §1.10.1, Revision 1, 2015).

Record retention

Batch-associated GMP records must be kept for at least one year after the expiry date of the respective product batch. For EU batch documentation, retain it for one year after batch expiry or at least five years after QP certification, whichever is longer (EudraLex Volume 4, Part I, Chapter 4 §4.11, revision 1, January 2011, effective 30 June 2011). The corresponding US requirement is 21 CFR §211.180(a), current eCFR text (2026), which generally sets a one-year-after-expiry period for batch-associated records and a separate period for certain OTC products exempt from expiry dating. Apply any longer period required by the relevant jurisdiction or marketing authorisation.

Frequently asked questions

Does the QP certify each batch before it is released?

Yes. For EU human medicines, the batch must be certified by a QP before release to the EEA market. Annex 16 also covers release for export (Directive 2001/83/EC Article 51; EudraLex Volume 4, Part I, Annex 16 §1.1, Revision 1, 2015; EMA Pre-authorisation guidance, question 3.3.2, revised March 2024).

Can the QP delegate work?

Supporting checks may be assigned to appropriately trained personnel or third parties. The QP must personally ensure the required conditions for certification are met and must make the certification decision (EudraLex Volume 4, Part I, Annex 16 §§1.6–1.7, Revision 1, 2015).

Can QPs share responsibility for a batch?

Yes. The roles and boundaries must be defined in a formally agreed document, including how deviations are evaluated (EudraLex Volume 4, Part I, Annex 16 §§1.4.2–1.4.3, Revision 1, 2015).

See also

• SOP for batch release of finished product
• Good Documentation Practice in the pharmaceutical industry

References

1. European Commission. EudraLex, Volume 4, Part I, Annex 16: Certification by a Qualified Person and Batch Release, Revision 1 (12 October 2015; effective 15 April 2016), §§1.1, 1.4, 1.6–1.7.21 and 1.10.1. Official PDF.
2. European Medicines Agency. Pre-authorisation guidance, question 3.3.2, “What batch release arrangements in the EEA are required for my medicinal products?” (revised March 2024), including questions 3.3.2.1–3.3.2.2. Official EMA page.
3. European Commission. EudraLex, Volume 4, Part I, Chapter 4: Documentation, revision 1 (January 2011; effective 30 June 2011), §4.11. Official PDF.
4. United States. 21 CFR §211.180(a), current eCFR text (2026). Official eCFR.