Pharmaceutical Quality Systems

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).

List of contents

Introduction. Experiences in the Inspecting of Quality Systems. GMP/ISO Quality Systems for Drug Products Manufacturers. Quality Management Systems & GMP. The Master Plan Concept. A Quality Manual for a Multinational Pharmaceutical Company. Implementation of a QA System into a German Pharmaceutical Company. Implementation of a Quality System. Experiences in the Auditing of QA Systems. How to Implement Validation into a QA System. How to Build a Supplier Qualification System. Hazard Analysis & Critical Control Points.

About the author

Oliver Schmidt

Product details

• Assisted by: Oliver Schmidt (Editor), Schmidt Oliver (Editor)
• Publisher: Taylor and Francis
• Languages: English
• Product format: Hardback
• Released: 30.04.2000
• EAN: 9781574911091
• ISBN: 978-1-57491-109-1
• No. of pages: 392
• Weight: 890 g
• Subjects: Natural sciences, medicine, IT, technology > Medicine > Non-clinical medicine; Social sciences, law, business > Business > Individual industrial sectors, branches; SCIENCE / Chemistry / Industrial & Technical, SCIENCE / Life Sciences / Genetics & Genomics, BUSINESS & ECONOMICS / Industries / Manufacturing, Industrial Chemistry, Manufacturing industries, Genetics (non-medical), Dna & Genome, SCIENCE / Bioinformatics, Computational biology / bioinformatics, Industrial chemistry and chemical engineering