Module 2: Quality Management

Abstract

Quality Management integrates design, planning, execution, control, and release of a process in order to achieve a pre-determined quality level. The process can be building a facility, procuring/installing equipment, or manufacturing a product. The module offers case studies and theory, and shows how common sense and GMP essentials allow the risks of given solutions to be assessed.

Objective

Quality Management (QM) is one of the pillars of Good Manufacturing Practices (GMPs). Anyone working in or for the pharmaceutical industry, particularly if in a managerial position, must be aware of the content and implications of GMPs, and must be able to correctly apply the GMP philosophy. QM is a high-level function that comprises (1) input of requirements at the design stage, (2) planning of quality oversight, (3) collection of feed-back, and (4) assessment of data in order to stabilize or improve quality. Quality Assurance (QA) ensures that the targets set by QM are met. Quality Control is the laboratory function that provides the data that QA acts upon. In a concrete setting, QM is confronted by the inevitable conflict between more regulation (reduction of real or formal risks) and maintaining feasibility (inherent limits in physics, chemistry, psychology, etc.). This sets the stage for responses that range from a scientifically underpinned can-do attitude to pedantry. The quality officer will have to justify his decision to auditors, etc and communicate it to colleagues in the affected departments. The aim of Module 2 is an introduction to Quality Management in pharmaceutical practice. Case studies and the cascade from regulations, guidelines, and SOPs to work instructions will be explored to tease out the basic notions of GMP. The students will analyze a given situation for risks (e.g. product quality and efficacy, patient safety) and requirements, and will propose a course of action, which will then be discussed in the light of current practices..

Content

The following areas will be touched upon: concept & regulatory requirements, risk management, infrastructure and equipment, qualification and validation, process development & scale-up, technology transfer, documentation, and quality organization.

Resources