Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

Quality Management Systems (QMS) in the Context of Planning for and Controlling the Quality of Drugs

Wolfram D. Hummel (Abschlußjahr: 2002)

The (pharmaceutical, biological) QUALITY of a drug is one of the three "main pillars" characterising and influencing its overall BENEFIT/RISK-RATIO. It further exerts interdependences to the other two product characteristics, namely SAFETY and EFFICACY, of which Safety is probably more likely to be influenced by varying Quality, and certainly of paramount concern. A high-level overview of the three basic international Quality Management Systems (QMS) in the pharmaceutical sector, GMP, GLP and GCP is presented, with a main focus on quality requirements, i.e. GMP. European and national German quality requirements are shortly addressed, as is the quality control of drugs in light of European drug regulations. Further, a gross overview on the generic QMS of the ISO 9000 family is presented and selectively highlighted regards the perspective of drug quality. Finally, a short comparison of some key aspects of the various QMSs in the context of drug quality is provided.

The serious and thorough application of a comprehensive and well-designed QMS equipped with all appropriate resources and full support by the company's top management is regarded indispensable to assure a drug's quality on one hand, and on the other hand constitutes a convincing opportunity for rewarding the company through improved effectiveness and efficiency as well as increased customer recognition for consistently high product quality.

Pages: 32