Pharmaceutical Quality Systems

1. Auflage 2000
ISBN: 978-1-57491-109-1
Verlag: CRC Press

Buch, Englisch, 392 Seiten, Format (B × H): 157 mm x 235 mm, Gewicht: 720 g

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.

Schmidt, Oliver

Fachgebiete

• Naturwissenschaften Biowissenschaften Biowissenschaften DNA und Transgene Organismen
• Wirtschaftswissenschaften Wirtschaftssektoren & Branchen Fertigungsindustrie
• Technische Wissenschaften Verfahrenstechnik | Chemieingenieurwesen | Biotechnologie Verfahrenstechnik, Chemieingenieurwesen

Inhaltsverzeichnis

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.

Über Autor(innen)

Oliver Schmidt