VALIDATION OF PHARMACEUTICAL PROCESSES, 3RD EDITION

JAMES AGALLOCO,FREDERICK J.CARLETON

ISBN 10: 0849370558 / ISBN 13: 9780849370557

Edité par CRC Press, 2007

Brand New. Soft Cover International Edition. Different ISBN and Cover Image. Priced lower than the standard editions which is usually intended to make them more affordable for students abroad. The core content of the book is generally the same as the standard edition. The country selling restrictions may be printed on the book but is no problem for the self-use. This Item maybe shipped from US or any other country as we have multiple locations worldwide. N° de réf. du vendeur ABNR-209832

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.<br><br>Presenting theoretical knowledge and applied practical considerations, this title<br><li>provides an in-depth discussion of recent advances in sterilization<br></li><li>identifies obstacles that may be encountered at any stage of the validation program, and suggests the newest and most advanced solutions <br></li><li>explores distinctive and specific process steps, and identifies critical process control points to reach acceptable results<br></li><li>blends the use of theoretical knowledge with recent technological advancements to achieve applied practical solutions<br></li>

À propos de l?auteur: James P. Agalloco, Frederick J. Carleton

Détails bibliographiques

Titre : VALIDATION OF PHARMACEUTICAL PROCESSES, 3RD ...
Éditeur : CRC Press
Date d'édition : 2007
Reliure : Couverture souple
Etat : New
Edition : 3ème Édition, Edition internationale