This is an ex-library book and may have the usual library/used-book markings inside.This book has hardback covers. Clean from markings In good all round condition. Please note the Image in this listing is a stock photo and may not match the covers of the actual item,1700grams, ISBN:9780849370557.

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Bibliographic Details

Title

Validation of Pharmaceutical Processes

Publisher

Informa Healthcare

Publication Date

2007

Language

English

ISBN 10

0849370558

ISBN 13

9780849370557

Binding

Hardcover

Edition

3rd Edition

Condition

Good

Weight

1700 grams

Seller catalogs

Medicine

About this title

Synopsis

Completely revised and updated to reflect the significant advances in pharmaceutical production and regulatory expectations, this third edition of Validation of Pharmaceutical Processes examines and blueprints every step of the validation process needed to remain compliant and competitive. The many chapters added to the prior compilation examine validation and six sigma system design; the preparation of aseptic and non-aseptic pharmaceutical products; active pharmaceutical ingredient and biotechnology processes, computerized systems; qualification and cleaning of equipment; analytical methods, calibration and certification. As the industry's leading source for validation of sterile pharmaceutical processes for more than 10 years, this greatly expanded is a comprehensive analysis of all of the fundamental elements of this arena with practical solutions for every pharmaceutical and bio-pharmaceutical production process.

Presenting theoretical knowledge and applied practical considerations, this title

provides an in-depth discussion of recent advances in sterilization

identifies obstacles that may be encountered at any stage of the validation program, and suggests the newest and most advanced solutions

explores distinctive and specific process steps, and identifies critical process control points to reach acceptable results

blends the use of theoretical knowledge with recent technological advancements to achieve applied practical solutions

About the Author

James P. Agalloco, Frederick J. Carleton

"About this title" may belong to another edition of this title.

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