Pharmaceutical Quality Systems

Herausgeber: Schmidt, Oliver

• Broschiertes Buch

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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Hinweis: Dieser Artikel kann nur an eine deutsche Lieferadresse ausgeliefert werden.

Produktdetails

• Verlag: Taylor & Francis Ltd (Sales)
• Seitenzahl: 392
• Erscheinungstermin: 19. September 2019
• Englisch
• Abmessung: 226mm x 152mm x 23mm
• Gewicht: 544g
• ISBN-13: 9780367398705
• ISBN-10: 0367398702
• Artikelnr.: 57816653

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.