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

Active Substances and Excipients

The Qualified Person must understand the influence of manufacturing pathways and associated physical and physico-chemical attributes, of both active substances and major excipients on the quality of the finished dosage form.

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

  • The steps commonly taken in the manufacture of small molecule Active Substances (AS) and excipients made by chemical synthesis, including their purpose and limitations

  • The steps commonly taken in the manufacture of large/ biological molecule and ATMP AS made by different pathways, including their purpose and limitations

  • The requirements of Good Manufacturing Practice as applied to the production of AS

  • The underlying principles, objectives, and limitations of the EDQM certificate of suitability

  • The pathways responsible for the generation of impurities or degradation products, and strategies for elimination, control, or removal of such impurities

  • Impact and control of solvents, catalysts, and process aids

  • The potential and avoidance of contamination and adulteration of AS and verification of the supply chain pedigree

  • The physico-chemical and biological properties of AS and excipients, and their effect on the attributes of the final dosage form

  • The principles of process validation applied to AS

  • The requirements for AS intended for use in sterile products

  • The requirements for control and declarations regarding adventitious infectious agents e.g. TSE

  • AS audit and QP declaration requirements.