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21 CFR Part 211 –Electronic/ Paper Records and Signature Requirements

Posted on January 29, 2014 by Helena Graham

Good Manufacturing Practice (GMP) for Finished Pharmaceuticals

Joe Brady PhD, Director of Global Compliance and Validation, Zenith Technologies, Portgate Business Park, Ringaskiddy, Cork, Ireland. Tuesday 28th January 2014

The following information is based upon and interpreted from GAMP® guidance and good practice recommendations. GAMP® is a registered trademark of ISPE: www.ispe.org. For more information see ‘A Risk Based Approach to Compliant Electronic Records and Signatures’, GAMP® Good Practice Guide, ISPE, (2005)

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