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CRC Press
392 pages
When a pharmaceutical company decides to build a Quality System, it has to face the fact that there aren't any guideline that define exactly how such a system has to be built. With terms such as quality system, quality assurance, and quality management used interchangeably, even defining the system's objectives is a problem. This book provides a practical guide to building a quality system. Beginning with explanations of key terms and concepts, it covers ISO 9000 and GMP and how to combine them, and includes a matrix showing their similarities and differences. Implementation reviews illustrate how Quality (Management) Systems have been installed successfully in pharmaceutical companies. Also covered are the individual components of a Quality System; auditing, validation, and supplier qualification systems; and Hazard Analysis Critical Control Points (HACCP).
Chapters:
o Introduction, O. Schmidt & R. Völler
o Experiences in the Inspecting of Quality Systems, R. Völler
o GMP/ISO Quality Systems for Drug Products Manufacturers, O. Schmidt
o Quality Management Systems & GMP, L. Hartmann
o The Master Plan Concept, K. Metzger
o A Quality Manual for a Multinational Pharmaceutical Company,
D. Sullivan
o Implementation of a QA System into a German Pharmaceutical Company, H. Prinz
o Implementation of a Quality System, O. Schmidt
o Experiences in the Auditing of QA Systems, A. Brutsche
o How to Implement Validation into a QA System, F. Demmer
o How to Build a Supplier Qualification System, W. Schumacher
o Hazard Analysis & Critical Control Points, M. Jahnke
