Pharmaceutical Quality Systems
Author:   Oliver Schmidt ,  Oliver Schmidt
Publisher:   Taylor & Francis Inc
ISBN:  

9781574911091


Pages:   392
Publication Date:   30 April 2000
Format:   Hardback
Availability:   In Print   Availability explained
This item will be ordered in for you from one of our suppliers. Upon receipt, we will promptly dispatch it out to you. For in store availability, please contact us.

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Pharmaceutical Quality Systems


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Overview

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).

Full Product Details

Author:   Oliver Schmidt ,  Oliver Schmidt
Publisher:   Taylor & Francis Inc
Imprint:   CRC Press Inc
Dimensions:   Width: 15.20cm , Height: 2.50cm , Length: 22.90cm
Weight:   0.890kg
ISBN:  

9781574911091


ISBN 10:   1574911090
Pages:   392
Publication Date:   30 April 2000
Audience:   Professional and scholarly ,  College/higher education ,  General/trade ,  Professional & Vocational ,  Postgraduate, Research & Scholarly
Format:   Hardback
Publisher's Status:   Active
Availability:   In Print   Availability explained
This item will be ordered in for you from one of our suppliers. Upon receipt, we will promptly dispatch it out to you. For in store availability, please contact us.

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.

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Oliver Schmidt

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