Pharmaceutical Quality Systems

When a pharmaceutical company decides to build a Quality System, it has to face the fact that there aren't any guidelines defining exactly how such a system has to be built. Beginning with explanations of key terms and concepts, this book 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).