Pharmaceutical Quality Systems: 1st Edition (Paperback) book cover

Pharmaceutical Quality Systems

1st Edition

Edited by Oliver Schmidt

CRC Press

392 pages

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Paperback: 9780367398705
pub: 2019-09-19
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Hardback: 9781574911091
pub: 2000-04-30
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Description

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).

Table of Contents

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.

About the Editor

Oliver Schmidt

Subject Categories

BISAC Subject Codes/Headings:
MED071000
MEDICAL / Pharmacology
SCI013000
SCIENCE / Chemistry / General