EU Annex 11 Guide to Computer Validation Compliance for the Worldwide Health Agency GMP
Download or Read eBook EU Annex 11 Guide to Computer Validation Compliance for the Worldwide Health Agency GMP PDF written by Orlando Lopez and published by CRC Press. This book was released on 2015-04-06 with total page 372 pages. Available in PDF, EPUB and Kindle.
Author | : Orlando Lopez |
Publisher | : CRC Press |
Total Pages | : 372 |
Release | : 2015-04-06 |
ISBN-10 | : 9781482243635 |
ISBN-13 | : 1482243636 |
Rating | : 4/5 (35 Downloads) |
Book Synopsis EU Annex 11 Guide to Computer Validation Compliance for the Worldwide Health Agency GMP by : Orlando Lopez
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