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

Pharmaceutical Quality Systems

The philosophy and basic principles of Quality Assurance, and roles of other functions throughout the product lifecycle

The design criteria for an effective PQS including but not limited to

·        auditing and self-inspections

·        management of quality and GMP at approved vendors and contractors

·        deviations, root cause analysis, corrective and preventive actions

·        process and product understanding

·        validation life cycle including computer systems

·        change and knowledge management

·        documentation, record management and data integrity

·        complaints and recalls

·        management review

·        training and competency assessment

The principles of Quality Risk Management for the assessment, control, communication, and review of risks to the quality of the medicinal product

The interpersonal skills (leadership, delegation, communication, teamwork etc.) necessary to implement an effective PQS

The principles of design, selection, introduction and maintenance of premises, equipment, utilities, and services to maintain the validated state

Calibration and preventative maintenance

The principles of purchasing and supplier certification, knowledge of supply chains and material control including but not limited to:

·        The roles of brokers, distributors and repackagers

·        Prevention of counterfeiting and illegal activities

·        Processes to support and verify the supply chain pedigree

·        Monitoring and control of both product and raw material transport and distribution processes

·        Production planning, scheduling, and inventory control and principles of GDP

·        Product quality reviews

·        Organisational structures and reporting relationships

·        Technical agreements in contract giving and acceptance.