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Pharmaceutical Reference Book from C.H.I.P.S.

Pharmaceutical Quality Systems
edited by Oliver Schmidt

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.

Pharmaceutical Quality Systems 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).

Contents

  1. Introduction
  2. Experiences in the Inspecting of Quality Systems
  3. GMP/ISO Quality Systems for Drug Products Manufacturers
  4. Quality Management Systems & GMP
  5. The Master Plan Concept
  6. A Quality Manual for a Multinational Pharmaceutical Company
  7. Implementation of a QA System into a German Pharmaceutical Company
  8. Implementation of a Quality System
  9. Experiences in the Auditing of QA Systems
  10. How to Implement Validation into a QA System
  11. How to Build a Supplier Qualification System
  12. Hazard Analysis & Critical Control Points

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Pharmaceutical Quality Systems
edited by Oliver Schmidt
392 pages • $258.95 + shipping
Texas residents please add 6.75 % sales tax

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