A new guide to becoming a qualified person in the pharmaceutical industry has been launched by the Royal Pharmaceutical Society, the Institute of Biology and the Royal Society of Chemistry.
The aim of the guide is to promote an increase in the number of people applying for registration as QPs. Companies are required by European law to have all batches of medicines signed off by a QP before they are released for distribution. The number of QPs available to the industry for the task is falling.
Speaking at the official launch of "Study Guide 2000" on January 20, Dr Nigel Hodges (chairman, study guide working party) said that over the past six years 240 persons had withdrawn from the QP register and only 105 new applications for registration had been made. This imbalance was likely to increase unless something was done about it.
One of the deterrents to an increased number of applicants was the difficulty in obtaining practical experience of the manufacturing of a comprehensive range of dosage forms. The new study guide sought to overcome this by having a core range of foundation elements and an additional range of knowledge requirements. These could be obtained for one dosage form and candidates would have to demonstrate how they could be extrapolated to other dosage forms (PJ, December 18/25, 1999, p972).
A principal objective of the working party which produced the new guide was to make the knowledge and experience required for QP registration more attainable without lowering the standards expected of QPs.