Responsibilities of a qualified person

The position of Qualified Person (QP) in a pharmaceutical company has a specific responsibilities. The QP must ensure that certain pre-requisites are fulfilled as described in Annex 16 to the EU GMP Guide. The QP is responsible for ensuring that each batch has been manufactured and checked in compliance with laws in force in the Member State where certification takes place, following the requirements of the marketing authorisation (MA) and with Good Manufacturing Practice (GMP)’.

Chantal: As a QP, I am responsible for releasing medicinal products by batch certification. This means that I review the documentation covering the entire production and quality control process, including defects or deviations from the process or product. The objective is to deliver an effective and safe product to the patient. Before batch certification becomes applicable, the QP should ensure that all critical manufacturing and quality control processes are validated according to the GMP guidelines.

The QP must rely on the Pharmaceutical Quality System (PQS) of the pharmaceutical company and should have an ongoing assurance that this reliance is well-founded. Therefore an understanding of the quality systems is required, for example (but not limited) deviation, out of specification (OOS), complaints management procedures as well as the methods of excursions on environmental monitoring and recall. Besides these so-called ‘problem solving’ processes, I should also have knowledge of the ‘compliance & oversight’ procedures in a pharmaceutical company, for example, annual Product Quality Review (PQR), change control and regulatory compliance. The batch is only released onto the market once the products from that batch have been certified.

When a QP releases a statement bearing the QP’s signature, he or she is personally responsible for its release. The oversight regarding ongoing investigations (complaints, out of trends, recalls) is required to evaluate if those are not impacting the batch certification of any medical product. This supervision by a QP is necessary to verify that a medicinal product was manufactured according to the GMP and MA guidelines and makes the responsibility of the QP significant. In Europe, every company must have access to a QP. Furthermore, the number of QPs in a company must correspond with the number of batches that company produces.

Progress can quickly and flexibly help companies needing a QP; accreditation by the Inspectorate is faster for QPs who have been registered as such before.