Qualified Persons (QP)A Qualified Person (QP) is somebody who plays a critical role in the Quality Assurance process for any company that manufactures and releases medicinal products. A Qualified Person’s duty is to ensure that no medicinal product is released for supply or sale without certification by an approved person (the QP).
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Requirements for Qualified Persons
A Qualified Person 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 be recognised and appointed by the MHRA. The criteria to be a recognised QP are extensive, but they include working in a pharmaceutical manufacturing operation and passing all relevant academic assessments in relation to the batch types they are releasing.
Products that can be released by a Qualified Person (QP) may include steriles, solid dosage forms, parallel import materials, and many more. For this reason, it is important that Qualified Persons have a broad exposure to the market, including most dosage forms.
The process of assessment to be eligible to be named as a QP on a pharmaceutical company’s 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 Qualified Persons due to time served in the industry (prior to the introduction of the permanent provisions) are recognised as QPs under Transitional provisions.
Clinical Trial Materials / IMPs (Investigational Medicinal Products) also come under the EU directive for regulated release, so you will find some Qualified Persons who specialise in IMP release as well as commercial products.
Due to the importance of medicinal products being released to the market and the ethical and safety matters associated with this, being 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 job opportunity. For this reason, HRS employ a number of experts with a track record of recruiting this skill set. Some of these experts are themselves members of the RSC.
A Qualified Person may be referred to by a variety of different job titles, including:
- Head of Quality & Regulatory (see Regulatory Affairs)
- Qualified Person
- Quality Manager
- Head of Quality
- Head of Compliance
- Compliance Manager
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