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QP - Qualified person

Cor Marsman on Qualified skills

The position of Qualified Person (QP) is a specialism bearing a heavy responsibility. A QP is the official in a pharmaceutical company who is responsible for releasing medicinal products. 

“As the QP, I am responsible for releasing medicinal products for marketing. This may only be done if the products are produced according to the criteria registered in the product dossier and with the GMP (Good Manufacturing Practice) criteria.”

A QP reviews the product documentation in the broadest sense. Cor: “This means that I monitor and review the documentation covering the entire production process, review documentation concerning defects or deviations from the process or product and evaluate whether the production process was validated correctly. The objective is to ultimately deliver an effective and safe product to the patient."

The batch is only released onto the market once the products from that batch have been certified. Cor: “When a QP releases a statement bearing his signature, he or she is personally responsible for its release.”

Supervision by a QP is necessary to verify that a medicinal product was manufactured according to the guidelines. 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. Cor: “Every company must find a balance in this respect.”

How can Progress-PME help you with this?
Progress-PME has enough experienced Qualified Persons to be able to quickly and flexibly help companies needing a QP; accreditation by the Inspectorate is faster for QPs who have been registered as such before. 

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