The Interactive QP Study Guide
This is an interactive (in development) copy of the 2022 QP study guide. The study guide specifies the areas of knowledge QPs are expected to be competent in. More specifically candidates are expected to “demonstrate understanding through application” in each of the areas generally described below.
An interactive guide, no matter how comprehensive it may become, will not provide an adequate substitute for first hand experience, but the content linked below is intended to give trainees a place to start and in some places a framework to orientate experience.
Foundation Knowledge
Pharmaceutical law and administration
European Pharmaceutical Directives
Marketing, Manufacturing and Wholesaler Authorisation structure, content, application and approval procedures, and responsibilities
The role, legal status, and structure of both the British and European Pharmacopoeias, including the certification procedure of the EDQM
The organisation of the UK MHRA, the role of the European Medicines Agency (EMA) and the role of the Veterinary Medicines Directorate (VMD)
Procedures for dealing with complaints and product recalls, the role of the MHRA’s Defective Medicines Report Centre, VMD’s defect reporting process and the EMA’s CHMP/CVMP guidelines on Quality
Pharmacovigilance regulations and requirements
The application and scope of Mutual Recognition Agreements (MRAs) between GB and other countries, and between EU and other countries, for Northern Ireland
How to interpret and apply the regulations concerning importation of pharmaceutical medicinal products from outside of GB and Northern Ireland;
Pharmaceutical Inspection Co-operation Scheme (PIC/S) and International Council for Harmonisation (ICH)