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Pharma Change Control - FDAnews

Pharma Change Control Strategies for Successful Company-Wide ImplementationThe Executive Briefing SeriesFrom the Editors ofCopyright 2013 by Washington Business Information Inc. All rights reserved. The Executive Briefing Series from The Food & Drug Letter (ISSN 0362-6466), is an in-depth analysis of regulations and issues affecting the pharmaceutical and biologics industries. The series is published monthly, 12 issues per year, for $4,995. Photocopying or reproducing in any form, includ- ing electronic or facsimile transmission, scanning or electronic storage is a violation of federal copyright law and is strictly prohibited without the publisher s express written permission.

Pharma Change Control: Strategies for Successful Company-Wide Implementation 5 product quality or reproducibility of the process. Change control procedures should en-sure that sufficient supporting data are generated to demonstrate that the revised process will result in a product of the desired quality, consistent with the approved specifications.

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