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GMP News Nr. 78
25 October 2000
Pharmaceutical Quality Systems
The following report was written by Dr. M. Jahnke on behalf of the APV News, published in "Die pharmazeutische Industrie", Issue 9/2000.
"The editor of the book entitled Pharmaceutical Quality Systems succeeded in recruiting ten competent authors from autority, university, and international pharmaceutical industry for to summarise and present their expert knowledge in Quality Systems within 12 chapters.
After presenting fundamentals and definitions of e.g. Quality, Quality Systems, and Quality Assurance experiences with Quality Systems based on the principles of GMP, ISO, and multinational pharmaceutical company are summarised. Topics such as GMP/ISO Quality Systems for Drug Products Manufacturers, Quality Management Systems and GMP and A Quality Manual for a Multinational Pharmaceutical Company should give an impression of the broad spectrum of subjects addressed.
Furthermore, aspects of the Master Plan concept, experiences and strategies for the (self-) Inspection of Quality Systems, and integration of Validation are analysed in detail and presented in a comprehensive manner.
Supplier Qualification Systems and a new trend in pharmaceutical Quality Systems, Hazard Analysis and Critical Control Points (HACCP), are described in the last chapters of the book.
The relevant national and international guidelines have been considered and each chapter gives a summary of relevant literature and recommended reading.
The reader is guided on a structured and systematic way trough 370 pages of information on various concepts of Quality Systems. For a prize of 169,-- US $ a compendium of condensed expert´s knowledge is presented that will encourage the reader to analyse the needs and strategies for the development of Quality Systems."
INTERPHARM PRESS, USA
Table of Contents