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.

Additional Knowledge

Investigational medicinal products

The manufacture, packaging, and distribution of Investigational Medicinal Products (IMP) must comply with GMP. There are significant differences between the manufacture and packaging of IMPs and licensed dosage forms which provide challenges. The Qualified Person must understand these differences together with the safeguards required to assure the quality of IMP supply..

Applicants will be expected to demonstrate understanding through application of the following:

  • The functions of a Qualified Person as set out in the UK SI and EU Clinical Trials Directive 2001/20/EC, as described in section 5.2

  • The structure, contents, control and application of the Clinical Trial Application (CTA) and Product Specification File (PSF)

  • Ethical considerations in the design & lifecycle management of the Clinical Trial to protect the safety of clinical subjects including pharmacovigilance and reporting requirements to meet the desired outcome and the role of the sponsor and ethics committee;

  • An understanding of clinical trial design at all phases (I, II, III and IV)

  • Controls surrounding the procurement, storage, distribution and control of IMP, Non-imps, placebo, licensed / un-licensed comparators, and rescue products

  • The underlying principles for the development, justification and application of the manufacture and control parameters for each phase of clinical trial, applying risk management principles to assure the safety and quality of the product, and additional requirements for sterile and biological products

  • What aspects of validation and qualification need to be completed prior to investigational medicinal product administration to a human subject. In addition, applicants must also be able to demonstrate risk-based approach to establish expectations of the level of validation/qualification required for equipment, cleaning, process, and test methods

  • The underlying principles and application of the control of packaging of investigational medicinal products in the conduct of Clinical Trials including labelling and blinding

  • Awareness of interpretation and application of Good Clinical Practice (GCP) and reporting of safety information

  • The requirements for effective batch documentation, control, sampling, testing and batch certification / release, including the control, certification and release of imported imps and comparators