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
Medicinal Chemistry and Therapeutics
The Qualified Person must have an understanding of the actions and uses of medicines in clinical practice in order to judge their significance for the manufacture of sales material or clinical trial supplies. Evaluating the significance of cross-contamination hazards or product complaints are examples where such knowledge is important.
The Qualified Person must understand the mode of action and uses of medicines in clinical practice to judge their significance for commercial or clinical trial supplies.
Applicants will be expected to demonstrate understanding through application of the following:
Basic physiology
Outline knowledge of the autonomic nervous system and some general aspects of chemical structure/pharmacological action relationships
Summary of key therapeutic drug classifications with examples
Examples of disease states and their treatment with medicinal products
General absorption, distribution, metabolism, and excretion of drugs
Principal routes of drug administration
Principles of good pharmacovigilance practice
General implications of clinical knowledge of drugs upon facility design (cross contamination control strategies, health based exposure limits (hbel)), plant segregation/isolation, cleaning verification and production scheduling
General implications of clinical knowledge of drugs in relation to complaint investigation, incidents, and deviations