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For 40 years, I’ve helped pharmaceutical businesses tackle regulatory, quality and supply chain challenges. I work alongside your team to build practical, compliant operations that protect patients and keep business moving.
The Role of the Qualified Person
The Qualified Person (QP) named on a pharmaceutical manufacturing or importation licence has a central responsibility for ensuring that medicinal products are manufactured, tested, released and distributed in accordance with applicable legal and regulatory requirements.
In the EU and UK, the QP must be appropriately qualified, experienced and named on the relevant licence, with sufficient authority and independence to perform these duties effectively.
Before certification for release, the QP reviews and relies on documented evidence that each batch has been manufactured and tested in compliance with the marketing authorisation, the principles and guidelines of Good Manufacturing Practice, and the requirements of the relevant licence.
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