Qualified Persons (QP)

A Qualified Person (QP) is somebody who plays a critical role in the Quality Assurance process for any company who manufacture and release a medicinal product. A Qualified Person’s (QP) duty is a pharmaceutical regulation in the EU which ensures no medicinal product is released for supply or sale without certification by an approved person (the QP).
Qualified persons

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The type of products which can be released by a Qualified Person (QP) can include steriles, solid dosage forms, parallel import materials as well as many more. For this reason it is important that the QP has a broad exposure to the market including most dosage forms.

A Qualified Person (QP) is likely to be a registered chemist, biologist or pharmacist and will have membership to the Royal Society of Chemistry (RSC), Society of Biology (SOB) or Royal Pharmaceutical Society of Great Britain (RPSGB). To become a QP all quality professionals must have a broad exposure to the market and be recognised and appointed by the MHRA to do so. The criteria to be a recognised QP is extensive but includes having experience working in a pharmaceutical manufacturing operation and passing all relevant academic assessments in relation to the batch types they are releasing.

The process of assessment to be eligible to be named as a QP on a pharmaceutical companies manufacturing license is known as the permanent provisions. This is an assessment method ending with a viva conducted by external assessors from the industry. Those who are recognised as a Qualified Person due to time served in the industry (prior to the introduction of the permanent provisions) are recognised as a QP under Transitional provisions.

Clinical Trial materials / IMPs (Investigational Medicinal Products) also come under the EU directive for regulated release and therefore you will find some Qualified Persons who specialise in IMP release as well as commercial product.

Due to the importance of medicinal products being released to the market and the ethical and safety matters associated with this, a Qualified Person is a niche and in demand skill with some large multinational companies having no more than a handful of such experts. This makes the recruitment process sometimes very challenging for clients who are looking for such specialists, and for a QP who is looking for a new opportunity. For this reason HRS has a number of experts with a track record of recruiting this skill set. Some of which themselves are a member of the RSC.

Some of the key job titles of a Qualified Person may be called: We are experienced and have a passion for supporting Qualified Person across all dosage forms and would welcome anybody interested in exploring new roles in this niche to get in touch to see how we can help you with you next steps.