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Cleaning Validation - A Brief Review

Vinod Thakor

ISBN 10: 3659194891 / ISBN 13: 9783659194894
Published by LAP LAMBERT Academic Publishing
New Condition: New Soft cover
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About this Item

Paperback. 80 pages. Dimensions: 8.5in. x 5.8in. x 0.2in.Validation is defined as the Action of proving, in accordance with the principles of Good Manufacturing Practice (GMP), that any procedure, process, equipment, material, activity or system actually leads to the expected results. (EC Guide to Good Manufacturing Practice, 1997). It is a requirement of GMP that each pharmaceutical manufacturer identify the validation work required to prove control of the critical aspects of their operations. Any aspect of, including significant changes to, the premises, the facilities, the equipment or the processes, which may affect the quality of the product, should be validated. This item ships from multiple locations. Your book may arrive from Roseburg,OR, La Vergne,TN. Bookseller Inventory # 9783659194894

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Bibliographic Details

Title: Cleaning Validation - A Brief Review

Publisher: LAP LAMBERT Academic Publishing

Binding: Paperback

Book Condition:New

Book Type: Paperback

About this title

Synopsis:

Validation is defined as the “Action of proving, in accordance with the principles of Good Manufacturing Practice (GMP), that any procedure, process, equipment, material, activity or system actually leads to the expected results.” (EC Guide to Good Manufacturing Practice, 1997). It is a requirement of GMP that each pharmaceutical manufacturer identify the validation work required to prove control of the critical aspects of their operations. Any aspect of, including significant changes to, the premises, the facilities, the equipment or the processes, which may affect the quality of the product, should be validated.

About the Author:

Mr. Vinod Thakor, (M.Pharm) is a PG Student at K. J. College of Pharmacy, Vadasma. Miss Vidhi M Desai, M.Pharm is a PG Student of SKPCPER, Ganpat Vidyanagar.Dr. Rajesh K Patel M. Pharm, Ph.D is a Associate Professor at K. J. College of Pharmacy, Vadasma.

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