Buch, Englisch, 392 Seiten, Format (B × H): 152 mm x 226 mm, Gewicht: 544 g
Buch, Englisch, 392 Seiten, Format (B × H): 152 mm x 226 mm, Gewicht: 544 g
ISBN: 978-0-367-39870-5
Verlag: CRC Press
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).
Zielgruppe
Academic and Professional Practice & Development
Autoren/Hrsg.
Fachgebiete
Weitere Infos & Material
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.
