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
Pharmaceutical Microbiology
The Qualified Person must understand the significance of the presence of bacteria, yeasts, moulds, viruses and toxins in pharmaceutical raw materials, products and production environments. In addition, they must understand how to prevent contamination by good product and facility design, GMP and control over starting materials, intermediates, finished products, production plant and processes, people and the environment.
Applicants will be expected to demonstrate an understanding of the following:
Sources and types of micro-organisms as related to pharmaceutical production
Production of sterile and non-sterile products and associated environmental controls
Bacterial endotoxins and pyrogens, their sources, removal and testing
Microbiology of water, its production and distribution systems; including different grades of water, their use, manufacture and control
Sterilisation and disinfection methods
Interpretation of microbiological data
Validation of microbiological test methods
Microbiological specifications
Selection and use of preservatives
Microbiological test methods used in routine manufacture and product development
Rapid methods of microbiological testing.