Qualified Person (QP) Certifications

Role of QPs

Every batch of a finished product must be certified by a QP in the EU before being released into market (DP batch release) or for clinical trials (IMP batch release). The QP must have detailed knowledge of the steps they are responsible for and be able to prove continuous training to maintain competency. Each manufacturing site in the EU must have at least one QP. Responsibilities can be shared with EU QPs if final certification of the batch is performed in another site than e.g. bulk manufacturing. For partial manufacturing operations inside the EU, a site’s QP confirms GMP compliance and adherence to the written agreement detailing the sites’ responsibilities.

Responsibilities of the QP

The QP must ensure that all activities associated with the manufacture and testing of the medicinal product comply with EU GMP principles. Documentation of the entire supply chain up to the stage of certification, including manufacturing and packaging sites and shipment, must be available for review. All audits of involved sites must be conducted, and audit reports should be available to the QP.

Ensuring compliance with manufacturing authorisation (MA)

The QP ensures that all manufacturing and testing activities are consistent with those described in the MA. Also source and specifications of starting materials and packaging materials must comply with the MA. Active substances used must be manufactured and, where required, distributed in accordance with EU GMP and Good Distribution Practice (GDP).

Additional quality checks

Compliance with directives related to excipients and Transmissible Spongiform Encephalopathy (TSE) status must be ensured​​. All records should be complete, endorsed, and all required in-process controls and checks made​​.

Quality control and stability

Finished product quality control test data must comply with the Finished Product Specification. Ongoing stability data should support the certification process​​.

Handling non-conformities and changes

Any non-conformity with a batch or change to product manufacturing or testing must be documented and evaluated. QP must be aware of non-conformity investigations and all relevant changes. Non-conformity investigation must be closed before a batch certification decision can be made.

Batch release

Batches should only be released for sale or supply after certification by a QP. Until certification, batches should remain at the site of manufacture or be shipped under quarantine to an approved site​​.

Safeguards (and notifications)

Safeguards to ensure that uncertified batches are not released for use should be in place, and the notification process for QP certification to the site where the transfer to saleable stock will occur should be defined in a technical agreement.