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View Full Version : Need copy of GEP guidance DRDDO 19th March 2009, 10:00 AM Dear All Did anyone have GEP Guidance = Good Engineering Practice for Medical devices. I need one :thanks: DRDEO MIREGMGR 19th March 2009, 12:14 PM Whose regulation or document would this be? Usually "Good xxxx Practice", where xxxx is some operational area of regulatory concern, is commonly regarded as an FDA document-titling approach. But, the expression "Good Engineering Practice" doesn't appear on the FDA CDRH website, which covers devices other than some combos and other special cases. Nissim Shaked 20th March 2009, 03:36 PM You can try and look for this book: "ISPE Good Practice Guide: Good Engineering Practice (Paperback)" Paperback Publisher: ISPE (2008) ISBN-10: 1931879540 ISBN-13: 978-1931879545 Its content is can be found at: http://www.ispe.org/galleries/publications-files/ISPE_GPG5_GEP_TOC.pdf |
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