Pharmacists wishing to become qualified persons (QPs) in the pharmaceutical industry may find it easier to gain certification from January 1, 2000, when a revised study guide setting out the knowledge and experience requirements comes into effect. The revision is designed to make the requirements more easily attainable without lowering standards.
The QP's role is to ensure that medicines manufacture is properly controlled; QPs have the duty of certifying that each batch of medicine is fit for release to the market place. The Royal Pharmaceutical Society sees pharmacists as ideally suited for QP status and is keen to encourage more pharmacists to seek certification, since the number of persons being certified as QPs each year is currently well below the number leaving the register of QPs.
Welcoming the revised study guide, the Society says that the pharmacy undergraduate course provides a perfect background for QPs, equipping candidates with broad-based knowledge covering most of the study guide. The practical experience requirement of just one year for pharmacists acknowledges that they are well placed to become QPs and fulfil a rewarding role in industry. The Society also points out that to fulfil the knowledge requirement pharmacists do not have to "re-do" their undergraduate studies - a common misconception. They can meet any gaps in their knowledge by attending relevant training courses and/or by private study.
To qualify for assessment as a QP, an applicant would normally be a member of the Royal Pharmaceutical Society, the Institute of Biology or the Royal Society of Chemistry (although arrangements are in place for assessing other suitably qualified applicants). Applicants must provide evidence of adequate knowledge of the subjects listed in the study guide and must demonstrate that they have relevant practical experience in one or more undertakings licensed to manufacture medicinal products. This experience must be of at least one year for pharmacists or at least two years for biologists and chemists.
The basic requirements for QPs are laid down by the European Union's pharmaceutical and veterinary directives (75/319/EEC and 81/851/EEC, respectively) and by ancillary legislation extending their scope to cover homeopathic, immunological, blood and radiopharmaceutical products. The directives' main requirement is that an applicant for a licence to manufacture products or to import products from outside the European Union must have available the services of a QP.
In the United Kingdom, the Medicines Control Agency and the Veterinary Medicines Directorate chose to interpret the directives' requirements through a study guide drawn up by an expert panel. They delegated to the three professional bodies the authority to assess the eligibility of their members. Members of these bodies who have been certified as eligible for nomination as a qualified person are listed in the Joint Register of Qualified Persons. The licensing authority is the final arbiter on who can be named as QP on a manufacturer's licence.
Applicants seeking certification must submit a completed application form, must be sponsored by two professional members (at least one of whom should normally be a member of the same professional body as the applicant), must pay an application fee and must undergo an oral assessment. During the assessment, applicants are expected to demonstrate their knowledge and experience and satisfy the assessors that they meet the requirements of the relevant directives. They should also be prepared to answer questions on any aspect of the study guide.
The revision of the study guide was prompted partly by the decline in the size of the QP register and partly by the fact that rationalisation and consolidation within the UK pharmaceutical industry have made it increasingly difficult for prospective candidates to gain the necessary experience of the full range of dosage forms. Recognising these concerns, the three bodies in 1997 established a working group to review the guide. The revised knowledge requirements identified by the group are divided into foundation knowledge (pharmaceutical law and administration; the role and professional duties of the qualified person; quality management systems) and additional knowledge (mathematics and statistics; medicinal chemistry and therapeutics; pharmaceutical formulation and processing; pharmaceutical microbiology; analysis and testing; pharmaceutical packaging; active pharmaceutical ingredients; investigational medicinal products). For each element, the study guide sets out the level of understanding expected, ranging from "a thorough understanding" to "an awareness".
Although the revision has not affected the length of practical experience required, applicants will be required to demonstrate in-depth knowledge and experience in only one major dosage form (eg, tablets, liquids, ointments, creams). They will be expected to be able to extrapolate their knowledge and experience into other dosage forms.
The ancillary documents regarding application for QP status have also been updated. They are available as a package.
Although "Study Guide 2000" is operational from January 1, 2000, a three-month transitional period will allow candidates to opt for assessment under either the existing or the revised study guide. Candidates who have acquired, or are acquiring, the necessary training and experience to satisfy the existing study guide should normally be able to fulfil the requirements of the new study guide.
General inquiries about the application process should be referred to Mrs Angela Attah, Secretary to the Industrial Pharmacists Group, Royal Pharmaceutical Society, 1 Lambeth High Street, London SE1 7JN (tel 020 7735 9141 ext 334).
Symposium on new QP study guideA half -day joint symposium, "Study Guide 2000: the launch" is to be held at the Royal Pharmaceutical Society's London headquarters on January 20, 2000. The meeting will aim to inform participants of the content and impact of the new information pack and study guide and the application process for attaining QP status. Further details are available from Angela Canning, Royal Pharmaceutical Society, 1 Lambeth High Street, London SE1 7JN (e-mail acanning@rpsgb.org.uk; fax 020 7582 3401). |
QP oral assessments in 2000The following are provisional dates for joint QP oral assessments in 2000: January 27, February 10 and 24, March 9, April 12, May 10 and 25, June 22, July 6 and 20, September 21, October 12 and November 23. The Society cannot guarantee the availability of a particular date until confirmation has been received that a candidate is considered suitable to attend an assessment. Candidates are advised to submit applications at least two months before the month in which they wish to be assessed. Final dates are determined jointly by the three professional bodies. |