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

Analysis and testing

The sampling and testing of materials do not themselves assure product quality, but are part of a comprehensive Pharmaceutical Quality System, which must be correctly implemented and controlled.

The data generated by laboratory testing of samples must be valid, representative, and evaluated before materials are certified and released for sale.

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

  • Quality Control (QC) and Good Laboratory Practice (GLP)

  • Specification development and lifecycle management to support product quality

  • Structured investigation of out of specification (OOS) and out of trend (OOT) results

  • The underlying principles, application and design of sampling regimes and their importance to achieving meaningful and accurate results

  • Sample retention and retesting

  • Pharmacopoeial monographs, test methods and general chapters

  • The principles of and interpretation of qualitative and quantitative analytical methods in common use for the analysis of medicinal products

  • The principles, methods and types, purpose, significance, and management of systems of in-process control

  • The principles, application and interpretation of biological analytical test methods and validation

  • The significance of degradation, contamination, and adulteration of pharmaceutical materials

  • The application of analytical techniques and sampling to cleaning verification and validation

  • The ICH guidelines for method validation, impurities, and stability testing

  • The principles, application, and interpretation of stability testing (protocols and methods), used during development to determine product shelf life and support ongoing marketing of the product

  • The principles, application, and design of analytical method transfers