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.
Foundation Knowledge
The role and professional duties of a Qualified Person.
The Legal and Routine duties of a Qualified Person as described in Annex 16, the level of oversight required; including detailed knowledge on the principles and application of ‘risk management’ within the pharmaceutical industry
How to interpret and apply the various International Conference on Harmonisation (ICH and VICH) guidelines
The key factors, product or process information or metrics that confirm that a batch of pharmaceutical product is suitable for certification and has been made to GMP
The principles and practice of current GMP as described within the GMP guidance including the Regulations made under the Human Medicines Regulations 2012 and MHRA guidance issued via their website, and within in European Directives/Regulations and EudraLex
The conduct and obligations of Marketing Authorisation (MA) and Manufacturer’s / Importer’s Authorisation (MIA) holders (and the equivalent for Veterinary Medicines)
The GMP requirements for Import and Export of medicinal products to GB and Northern Ireland
The conduct and obligation of Clinical Trial Sponsors and Investigational Medicinal Product providers
The role of the QPPV and the interactions between the QP and QPPV
The preparation and management of Regulatory Inspections
The requirements and responsibilities of the QP regarding Active Substances or Investigational Medicinal Product declarations
The requirements for QPs when acting as independent contractors or on behalf of third parties.