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 Packaging

It is a requirement of GMP that holders of a Licences establish procedures for their packaging operations to minimise the risk of cross-contamination, mix-up, or substitutions. The Qualified Person must understand the importance of controlling packaging components (both primary and secondary, including printed materials) throughout the supply chain to assure the quality of finished products.

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

  • Control of packaging components by suppliers and throughout production

  • The chain of systems which ensure the integrity and accuracy of textual information from originator to routine production, including artwork generation, text approvals and regulatory submission / implementation requirements

  • The testing of packaging materials as part of incoming goods checks, including the application of sampling regimes and assurance of outsourced activities

  • The potential root causes of label and other printed component mix-ups and how they can be identified and eliminated

  • The optimum layout, organisation and control of packaging operations, different types of packaging and labelling processes and equipment, including the consideration of the type of equipment required for high volume / high speed operations and smaller / manual operations

  • The underlying principles and application of in-process controls conducted during packaging operations, including line clearance, pack integrity testing, challenge testing, reconciliation, bar coding and optical systems

  • The design and completion of packaging batch records, including full traceability of all product and materials for investigation and recall purposes

  • Effects of packaging materials on product stability

  • The requirements and desirability of tamper-evidence, anti-counterfeiting measures and general supply chain security