Pharmaceutical Quality Systems (eBook, ePUB)

Redaktion: Schmidt, Oliver

• Format: ePub

Produktbeschreibung

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).

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Produktdetails

• Verlag: Taylor & Francis
• Erscheinungstermin: 30. April 2000
• Englisch
• ISBN-13: 9781040204139
• Artikelnr.: 72538890

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.