The Pharmaceutical Journal
Vol 270 No 7245 p546
19 April 2003

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Letters to the Editor

Qualified persons

Academia is doing its bit to encourage pharmacists

From Mr T. J. Sizer, MRPharmS, and Mr B. Midcalf, FRPharmS

We read with interest the article by Dr Malcolm Brown relating to Qualified Persons (PJ, 29 March, p434). We are in sympathy with the three action points of greater publicity for the role of QP, encouraging more interest in QP duties at undergraduate level and further consideration of pharmacists for a QP role as a potential career change.

We are doing what we can in "the world of academia" to encourage training opportunities for experienced pharmacists.

It has been noted by some influential professionals and members of the pharmaceutical industry, that the experienced pharmacist has a number of unique characteristics that make them best suited as a QP. The combination of wide ranging academic experience provided by a pharmaceutical education facilitates a broad level of understanding of many related scientific disciplines and principles.

It is logical to attempt the recruitment of a pharmacist as a QP by preference wherever practical. In this way the greater wealth of understanding of pharmaceutical sciences may be exploited for the safe and considered release on to the market place, of licensed medicinal products. The merits of pharmacists are naturally used in a range of medical disciplines and their influence in the clinical environment has rightly been recognised as a valuable contribution to patient care. This development of clinical pharmacy is a valued and supportive process, as is the continued expertise in traditional pharmacy, the compounding, manufacture and control of medicinal products.

The Qualified Person is essential to the safe control of medicines and needs to have extensive training and in-depth critical understanding of all the many aspects associated with pharmacy manufacturing. To acquire the necessary experience and training is not so simple.

It may be of interest to know that a specialist training course leading to the acquisition of the knowledge base required as a QP has been developed and has offered training to four cohorts of students over an eight-year period. It is administered by the University of Leeds as part of the activities of the School of Continuing Education. It is known as "Pharmaceutical technology and quality assurance" and is taught by a large number of experienced specialists from the national Health Service and the industry. Through a series of six modules over two years it provides a residential taught session followed by continued learning in the workplace, written assignments and examination. A final research project can then lead to an MSc degree. Alternatively, students may leave at the certificate or diploma level. Further information can be retrieved from here.

The course provides the knowledge base for a QP and successful students are awarded an MSc degree but graduates do not become a QP until after a period of work experience in a licensed manufacturing unit with a PL product. QPs are appointed following a successful viva with the joint consultative body (Royal Pharmaceutical Society, Royal Society of Chemistry and Institute of Biology).

Tim Sizer
Brian Midcalf
Pharmaceutical Technology and Quality Assurance Course Administrators
University of Leeds

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