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 formulation and processing
The formulation and processing conditions employed in the manufacture of medicinal and combination product dosage forms have a significant effect upon their safety, quality, and efficacy. Even subtle changes to the input materials and/or processing conditions can have a profound adverse effect on content uniformity, stability, bioavailability, and other attributes which are not detectable by routine QC testing.
It is vitally important that the Qualified Person understands the principles of formulation and pharmaceutical processing to ensure that informed certification and release decisions are made.
Applicants will be expected to demonstrate understanding through application of the following:
The major processing techniques (chemical, biological, biotech and ATMP), their limitations, critical quality attributes and critical control parameters
The factors that could potentially affect purity, content uniformity, stability (chemical, physical, and microbiological) and bioavailability in manufacture
The principles of process validation and control
The principles of technology transfer and production scale-up
The principles of new manufacturing technologies
The principles of continuous manufacturing
Quality critical attributes and in-process tests
Pre-formulation studies and product development
The storage and distribution of materials and finished products.