EU Annex 11 Guide to Computer Validation Compliance for the Worldwide Health Agency GMP

EU Annex 11 Guide to Computer Validation Compliance for the Worldwide Health Agency GMP
Author :
Publisher : CRC Press
Total Pages : 262
Release :
ISBN-10 : 9781040083703
ISBN-13 : 1040083706
Rating : 4/5 (706 Downloads)

Book Synopsis EU Annex 11 Guide to Computer Validation Compliance for the Worldwide Health Agency GMP by : Orlando Lopez

Download or read book EU Annex 11 Guide to Computer Validation Compliance for the Worldwide Health Agency GMP written by Orlando Lopez and published by CRC Press. This book was released on 2015-04-06 with total page 262 pages. Available in PDF, EPUB and Kindle. Book excerpt: Good Manufacturing Practice (GMP) ensures medicinal products are produced consistently and controlled to the quality standards appropriate for their intended use and as required by product specifications or marketing authorization. Annex 11 details the European Medicines Agency (EMA) GMP requirements for computer systems.The purpose of Annex 11 is


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