Centre for Molecular Oncology and Imaging
Barts Institute of Cancer
Queen Mary University of London
The role of the qualified person (QP) has been established in the industrial manufacture of pharmaceuticals for some years. The role of the QP is to ensure that every batch of medicine complies with its Marketing Authorisation and has been made according to Good Manufacturing Practice. He/she may also assess the quality of imported medicines for use within the EU. To become a QP a candidate has to meet certain requirements as defined in the European Directive (2001/83/EC). As interpreted in the UK, the person is required to possess a suitable degree, has acquired the ”body of knowledge” considered necessary for a QP, and has acquired practical experience of working under a pharmaceutical manufacturing licence. The candidate must also successfully undergo an in-viva examination by a panel of assessors who will decide if he/she can be given QP eligibility status. The final decision to approve an individual to act as a QP rests with the Medicines and Health products Regulatory Agency (MHRA), after which the QP is named on the manufacturing licence for the site(s) concerned.
Although well established in industrial manufacture, QPs have not been widely utilised in hospital-based manufacturing activities because few hospitals operate under full manufacturing licences. Most production in the NHS is covered by the manufacturing (Specials) licence system. This unique UK-based system allows small-scale manufacture to be performed within a quality management system that does not formally require the appointment of a QP, although it does require a named person to be responsible for quality control.
However, the implementation of the European Clinical Trials Directive and the subsequent Medicines for Human Use (Clinical Trials) Regulations 2004 in the UK introduced the need for a QP in any site manufacturing drugs for use in clinical trials, (known as investigational medicinal products or IMPs) irrespective of whether this manufacture was performed in industry or hospitals. Fortunately, transitional arrangements were put in place whereby anyone who had been performing the duties of a QP at the time the legislation came into force could be considered to be eligible for QP status under the new Regulations. As a result around 20 to 30 people were able to achieve this status and this has enabled IMP manufacture to continue in many UK hospitals.
However some problems remain. Some potential IMP manufacturing sites failed to meet the deadline for the implementation of the transitional arrangements. Many of the transitional QPs were experienced individuals who have since retired, whereas others have moved from their original employers to positions elsewhere, creating a vacancy to which it has been difficult to recruit a qualified applicant. This has resulted in a shortage of QPs in hospital- and academic-based manufacturing sites; a situation that is likely to worsen as a result of further retirements and job mobility. This will have a severe impact on the ability of such institutions to support clinical trials where on-site manufacture of pharmaceuticals is required. This situation is particularly relevant to the manufacture of radiopharmaceuticals which, as a result of their short shelf-life, often need to be manufactured at the clinical site. Unless action is taken to increase the number of QPs working in the NHS and academia in the immediate future, this shortage is likely to place a severe limitation on the ability of the NHS to perform clinical trials of radiopharmaceuticals (as well as other novel agents) in the UK in the medium term.
Addressing the shortage
Since the transitional period has been closed for some years, the only way in which this shortage can be addressed is for additional individuals to qualify as new QPs. Unfortunately, few people are pursuing this route. The reasons for this apparent reluctance of hospital-based pharmacists and healthcare scientists to pursue a QP role are uncertain but appear to include a number of perceived and real obstacles. As outlined above there are four principal requirements for becoming a QP: a degree in a suitable subject (chemistry, pharmacy, medicine, veterinary medicine, pharmaceutical chemistry and technology or biology); acquisition of the required body of specialised knowledge as defined in the QP Study Guide1; practical experience of working under a pharmaceutical manufacturing licence (one year for pharmacists and two years for other disciplines); and, application to, and assessment by, one of the involved professional bodies (Royal Pharmaceutical Society, Royal Society of Chemistry or the Institute of Biology) or, in some circumstances, the MHRA. The application must be supported by a ”sponsor”; a practising QP who is a member of one of the professional bodies and has known the candidate during his/her period of experience.
The ”body of knowledge” required is described in detail in the study guide.1 It comprises a broad range of subjects including pharmaceutical law and administration, the role and professional duties of a QP, quality management systems, mathematics and statistics, medicinal chemistry and therapeutics pharmaceutical formulation and processing, pharmaceutical microbiology, analysis and testing, pharmaceutical packaging, and active pharmaceutical ingredients and IMPs. A number of dedicated courses exist to teach this syllabus to potential QPs but these courses are relatively expensive and typically take several years to complete, so attendance on such a programme would be difficult for a candidate working in the cash-strapped NHS. However there is, in fact, no formal requirement for potential QPs to obtain their theoretical knowledge through one of these dedicated courses. An individual can acquire this knowledge in many different ways including first and postgraduate degree programmes, specialised courses, workshops and private reading. Candidates will, however, be required to describe on their application how this knowledge has been obtained. Acquisition of the body of knowledge can therefore be considered to be a perceived, rather than real, barrier to becoming a QP.
The main hurdle is the period of practical work experience required. Those working in the pharmaceutical industry can obtain this experience quite easily because most companies possess a full Manufacturing Licence. However, this is not the case in the NHS and few will be able to obtain their experience in this way. Work undertaken under a ‘Specials’ licence is not eligible towards this experiential requirement so in effect the only way in which someone can gain the required experience while working in hospital is under an existing MIA (IMP) licence. A hospital wishing to acquire its first such licence faces real difficulty in recruiting a QP to be named on the licence or training an existing employee to fill this role but the possibility does exist for someone to gain this experience during full or part-time secondment to another hospital provided that a formal honorary contract exists between the institution and the individual.
Subjects covered during work experience
At the present time, unlike the detailed requirements set out for the theoretical body of knowledge, little detail is provided for the subjects that must be covered during this work experience, only that the candidate must show “thorough core competence in the manufacturing processes and the quality management systems involved in the production, testing, batch release and approval for sale of the products made under the Manufacturer’s Licence(s) under which he or she is claiming his or her qualifying experience”, and must “demonstrate an ability to translate and extrapolate the working knowledge and understanding gained from his or her experience”.1
This lack of detail may not be a problem when the candidate is working full-time in industry because most of the work activities will be covered by a full Manufacturing Licence; however, IMP production in hospitals is often sporadic and interspersed among other activities. To optimise the experience gained working under a hospital system, it would be helpful if a list of required topics, similar to those listed in the theoretical body of knowledge, was produced.
Members of the UK Radiopharmacy Group and the NHS Pharmaceutical Quality Assurance Committee have recently joined forces to encourage and help those healthcare professionals working in the NHS to apply for, and achieve, QP status.2 With funding from the NHS Pharmaceutical Technical Specialists Education and Training Group, a list of competencies that would be appropriate for hospital-based QPs and which potential candidates could usefully aim to achieve during their period of practical work experience has been produced. Preparation of a list of hints and tips for applicants and their sponsors, as well as developing a scheme to support training and secondments between NHS manufacturing sites, is planned. It is hoped that these initiatives will result in an increase in the number of individuals applying and obtaining QP status in the years to come.
1. Royal Pharmaceutical Society of Great Britain. www.rpsgb.org/worldofpharmacy/workingwithotherbodies/qualifiedpersonscheme/.
2. Mather, SJ et al. Nuclear Med Comm 2010;31:187–9.