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)."--Provided by publisher.

Chapter 1 Introduction in Quality Systems -- chapter 2 Experiences in the Inspecting of Quality Systems?An Inspector's View -- chapter 3 GMP/ISO Quality Systems for Drug Products Manufacturers -- chapter 4 Quality Management Systems and GMP -- chapter 5 The Master Plan Concept: GMP-Compliant Production in a Non-GMP Environment -- chapter 6 A Quality Manual for a Multinational Pharmaceutical Company -- chapter 7 Implementation of a Quality Assurance System into a German Pharmaceutical Company -- chapter 8 ; Implementation of a Quality System: A Report of Practical Experience -- chapter 9 Experiences in the Auditing of Quality Assurance Systems: Industry's View -- chapter 10 How to Implement Validation into a QA System -- chapter 11 How to Build a Supplier Qualification System -- chapter 12 Hazard Analysis and Critical Control Points in a Pharmaceutical QA System.