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Author : Ispe
Publisher :
ISBN 13 : 9781946964335
Total Pages : pages
Book Rating : 4.36/5 ( download)
Download or read book ISPE GAMP® RDI Good Practice Guide: Data Integrity by Design written by Ispe and published by . This book was released on 2020-11-17 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Ispe
Publisher :
ISBN 13 : 9781946964199
Total Pages : 152 pages
Book Rating : 4.90/5 ( download)
Download or read book ISPE GAMP® RDI Good Practice Guide written by Ispe and published by . This book was released on 2019-06-07 with total page 152 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : ISPE: International Society for Pharmaceutical Engineers
Publisher :
ISBN 13 : 9781946964106
Total Pages : 240 pages
Book Rating : 4.07/5 ( download)
Download or read book ISPE Baseline® Guide written by ISPE: International Society for Pharmaceutical Engineers and published by . This book was released on 2018-04-25 with total page 240 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Good Automated Manufacturing Practice Forum
Publisher :
ISBN 13 : 9781936379507
Total Pages : 272 pages
Book Rating : 4.03/5 ( download)
Download or read book A Risk-based Approach to Testing of GxP Systems written by Good Automated Manufacturing Practice Forum and published by . This book was released on 2012 with total page 272 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : David Roesti
Publisher : John Wiley & Sons
ISBN 13 : 1119356075
Total Pages : 594 pages
Book Rating : 4.73/5 ( download)
Download or read book Pharmaceutical Microbiological Quality Assurance and Control written by David Roesti and published by John Wiley & Sons. This book was released on 2020-01-02 with total page 594 pages. Available in PDF, EPUB and Kindle. Book excerpt: Relying on practical examples from the authors’ experience, this book provides a thorough and modern approach to controlling and monitoring microbial contaminations during the manufacturing of non-sterile pharmaceuticals. Offers a comprehensive guidance for non-sterile pharmaceuticals microbiological QA/QC Presents the latest developments in both regulatory expectations and technical advancements Provides guidance on statistical tools for risk assessment and trending of microbiological data Describes strategy and practical examples from the authors’ experience in globalized pharmaceutical companies and expert networks Offers a comprehensive guidance for non-sterile pharmaceuticals microbiological QA/QC Presents the latest developments in both regulatory expectations and technical advancements Provides guidance on statistical tools for risk assessment and trending of microbiological data Describes strategy and practical examples from the authors’ experience in globalized pharmaceutical companies and expert networks
Author : Sion Wyn
Publisher :
ISBN 13 : 9781931879613
Total Pages : 0 pages
Book Rating : 4.13/5 ( download)
Download or read book GAMP 5 written by Sion Wyn and published by . This book was released on 2008 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: GAMP 5 provides pragmatic and practical industry guidance to achieve compliant computerized systems fit for intended use in an efficient and effective manner. This technical document describes a flexible risk-based approach to compliant GxP regulated computerized systems, based on scalable specification and verification. It points to the future of computer systems compliance by centering on principles behind major industry developments such as PQLI; ICH Q8, Q9, Q10; and ASTM E2500. This revolutionary Guide addresses the entire lifecycle of an automated system and its applicability to a wide range of information systems, lab equipment, integrated manufacturing systems, and IT infrastructures. It contains new information on outsourcing, electronic batch recording, end user applications (such as spreadsheets and small database applications), and patch management.
Author :
Publisher : Ispe Headquarters
ISBN 13 : 9781931879392
Total Pages : pages
Book Rating : 4.97/5 ( download)
Download or read book GAMP Good Practice Guide written by and published by Ispe Headquarters. This book was released on 2005-01-01 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : ISPE
Publisher :
ISBN 13 : 9781931879255
Total Pages : 19 pages
Book Rating : 4.57/5 ( download)
Download or read book GAMP Good Practice Guide written by ISPE and published by . This book was released on 2002 with total page 19 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Ispe
Publisher :
ISBN 13 : 9781936379187
Total Pages : 136 pages
Book Rating : 4.8X/5 ( download)
Download or read book ISPE Good Practice Guide written by Ispe and published by . This book was released on 2011-10-18 with total page 136 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author :
Publisher :
ISBN 13 : 9781936379842
Total Pages : 162 pages
Book Rating : 4.48/5 ( download)
Download or read book ISPE Good Practice Guide written by and published by . This book was released on 2016 with total page 162 pages. Available in PDF, EPUB and Kindle. Book excerpt:
