Transcription of Pharma Change Control - FDAnews
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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.
Written procedures should be in place to describe the actions to be taken if a change is proposed to a product component, process equipment, process environment (or site), method of production or testing or any other change that may affect product quality or support sys-tem operation.” (PIC/S document PI 006, section 6.7.1)
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