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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 :
Publisher : Ispe Headquarters
ISBN 13 : 9781931879422
Total Pages : pages
Book Rating : 4.27/5 ( download)
Download or read book GAMP Good Practice Guide written by and published by Ispe Headquarters. This book was released on 2005 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 : 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
ISBN 13 : 9781931879385
Total Pages : pages
Book Rating : 4.89/5 ( download)
Download or read book GAMP Good Practice Guide written by and published by Ispe. This book was released on 2005 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Author : Joachim Ermer
Publisher : John Wiley & Sons
ISBN 13 : 3527604472
Total Pages : 418 pages
Book Rating : 4.70/5 ( download)
Download or read book Method Validation in Pharmaceutical Analysis written by Joachim Ermer and published by John Wiley & Sons. This book was released on 2006-03-06 with total page 418 pages. Available in PDF, EPUB and Kindle. Book excerpt: Adopting a practical approach, the authors provide a detailed interpretation of the existing regulations (GMP, ICH), while also discussing the appropriate calculations, parameters and tests. The book thus allows readers to validate the analysis of pharmaceutical compounds while complying with both the regulations as well as the industry demands for robustness and cost effectiveness. Following an introduction to the basic parameters and tests in pharmaceutical validation, including specificity, linearity, range, precision, accuracy, detection and quantitation limits, the text focuses on a life-cycle approach to validation and the integration of validation into the whole analytical quality assurance system. The whole is rounded off with a look at future trends. With its first-hand knowledge of the industry as well as regulating bodies, this is an invaluable reference for analytical chemists, the pharmaceutical industry, pharmaceutists, QA officers, and public authorities.
Author : R. D. McDowall
Publisher : Royal Society of Chemistry
ISBN 13 : 178801281X
Total Pages : 660 pages
Book Rating : 4.12/5 ( download)
Download or read book Data Integrity and Data Governance written by R. D. McDowall and published by Royal Society of Chemistry. This book was released on 2018-11-09 with total page 660 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides practical and detailed advice on how to implement data governance and data integrity for regulated analytical laboratories working in the pharmaceutical and allied industries.
Author : Guy Wingate
Publisher : CRC Press
ISBN 13 : 1420088955
Total Pages : 773 pages
Book Rating : 4.53/5 ( download)
Download or read book Pharmaceutical Computer Systems Validation written by Guy Wingate and published by CRC Press. This book was released on 2016-04-19 with total page 773 pages. Available in PDF, EPUB and Kindle. Book excerpt: Thoroughly revised to include the latest industry developments, the Second Edition presents a comprehensive overview of computer validation and verification principles and how to put them into practice. To provide the current best practice and guidance on identifying and implementing improvements for computer systems, the text extensively reviews regulations of pharmaceuticals, healthcare products, blood processing, medical devices, clinical systems, and biotechnology. Ensuring that organizations transition smoothly to the new system, this guide explains how to implement the new GMP paradigm while maintaining continuity with current practices. In addition, all 24 case studies from the previous edition have been revised to reflect the new system.
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
Publisher :
ISBN 13 : 9781946964144
Total Pages : 148 pages
Book Rating : 4.4X/5 ( download)
Download or read book ISPE Good Practice Guide written by Ispe and published by . This book was released on 2019-01-24 with total page 148 pages. Available in PDF, EPUB and Kindle. Book excerpt:
