The Pharmaceutical Journal
Vol 268 No 7188 p345
9 March 2002
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The Pharmaceutical Journal |
Industrial Pharmacists Group
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How about a career as a Qualified Person? [more] |
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How about a career as a Qualified Person?
The Royal Pharmaceutical Society's Industrial Pharmacists Group is keen to see more pharmacists taking up careers as Qualified Persons (QPs) in the pharmaceutical industry. The concept of "Qualified Person" was introduced by European Community Directive 75/319/EEC because of a need for someone to certify that each batch of a medicinal product has been manufactured in accordance with its marketing authorisation (product licence) and in compliance with good manufacturing practice. The QP is named on the product licence. Should the product be found deficient, it is the QP who is held responsible, not the company. Pharmacists, of course, are used to such responsibility in dispensing practice. The directive states that a potential QP should have sufficient knowledge to understand the importance of variations on the quality and efficacy of the substances being manufactured. The knowledge required (see Panel) is effectively the same as that needed by pharmacy graduates. However, because the industry employs many other science graduates, the list of persons who can become QPs also includes graduates in chemistry, biology, medicine and veterinary medicine, provided that they can demonstrate the requisite basic knowledge. To ensure that everyone named on the product licence has the required knowledge, the regulatory bodies are required to keep a register of people who were suitably qualified to operate as QPs. In the United Kingdom, this responsibility was delegated to the Royal Pharmaceutical Society, the Royal Society of Chemistry and the Institute of Biology, which operate this function as a Joint Professional Bodies' Panel. The three professional bodies have prepared a study guide,1 which can be obtained from the Industrial Pharmacists Group page in the "About the Society" section of the Society's website. They are also responsible for ensuring that QPs are subject to a strict code of practice as defined by the initial legislation. Recent articles2,3 have described the challenges and opportunities for pharmacists wishing to pursue a career in industry. Of the options available, becoming a QP offers an exciting and challenging career. Graduates who have completed a year or two in community or hospital pharmacy practice have a good understanding of how medicines are used. They will also have observed how patients respond to various drugs and have become aware of the consequences of side effects. At this point a move into industry in either manufacturing or quality assurance would be a pertinent career change for those aspiring to be QPs. In addition to the specified basic knowledge, QPs are required to have a specified minimum industrial experience, which for a pharmacy graduate is only one year. But considerably more than this minimum is really needed, not only to achieve a sufficient level of responsibility within the company, but also to have the knowledge and confidence to carry out the QP function. For much of the time this function is fairly easy, but the real test comes when raw material variation or other manufacturing issues arise that are not precisely quantifiable. The emphasis of pharmacy courses has changed over the years from formulation and manufacturing to clinical skills, reflecting the way in which most pharmacists now practise. This means that most pharmacy graduates aspiring to QP status need some additional training in understanding the effect of material and process variation. But their clinical skills will enable them to be aware of the consequence of variations on the clinical efficacy of the product. The new pharmacy degree syllabus should go some way to providing the requisite knowledge. In addition to obtaining a suitable degree and registering with the appropriate professional body, candidates for QP status have to undergo a viva voce examination by a panel of QPs drawn from the three professional bodies and chaired by a member of the same professional body as the candidate. The interview ranges over issues that may arise during manufacture and will almost certainly require the candidate to have training in addition to their degree. This training can take a number of routes, and personal needs can be taken into account. Some candidates choose to study only those parts of the syllabus in which they feel their knowledge is limited, but experience suggests that candidates need to cover the whole syllabus, especially if they graduated more than five years before preparing to become a QP. For example, the syllabus provides an understanding of current legislation affecting the manufacture and supply of medicinal products. It also leads to a greater in-depth knowledge of processing technologies than is provided by most degree courses. However, this study could always be done at the same time as obtaining the relevant industrial experience. Complete courses are offered by two universities and by one industrial-based training organisation in association with a university. In addition, individual components are offered by the three professional bodies (and by associated professional sections such as the Pharmaceutical Quality Group). Contact addresses appear below. Contacts for QP training Course Administrator, Postgraduate Diploma in Industrial Pharmaceutical Studies, School of Pharmacy and Biomolecular Sciences, University of Brighton, Moulsecoomb, Brighton BN2 4GJ (tel 01273 642118) Department of Chemistry, University of Greenwich, Wellington Street, London SE18 6PF (tel 020 8331 8000) David Begg Associates, 10 High Market Place, Kirbymoorside, York YO6 6AX (tel 01751 432450) Industrial Pharmacists Group, Royal Pharmaceutical Society, 1 Lambeth High Street, London SE1 7JN (website www.rpsgb.org.uk) Royal Society of Chemistry, Burlington House, Piccadilly, London W1V 0BN (website www.rsc.org) Institute of Biology, 20-22 Queensbury Place, London SW7 2DZ (website www.iob.org)
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What a QP should knowEuropean Community legislation requires a QP to have knowledge covering the following: Law, specifically that relating to the manufacture, sale and supply of medicinal products Physical and chemical properties of materials, and how these affect the manufacture, stability and degradation of products Process technologies, particularly those relating to the manufacture of their products Microbiology of the products and systems in use Pharmacology of the active pharmaceutical ingredients used in their products Clinical implications of process and material variation |
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