Oliver Schmidt (ed.)

Pharmaceutical Quality Systems

Herausgeber: Schmidt, Oliver

• Gebundenes Buch

Produktbeschreibung

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).

Produktdetails

• Verlag: CRC Press
• Seitenzahl: 392
• Erscheinungstermin: 30. April 2000
• Englisch
• Abmessung: 233mm x 153mm x 25mm
• Gewicht: 680g
• ISBN-13: 9781574911091
• ISBN-10: 1574911090
• Artikelnr.: 23309493

Autorenporträt

Oliver Schmidt

Inhaltsangabe

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.