GAMP Good Practice Guide
Author:
Publisher: Ispe Headquarters
Published: 2005-01-01
Total Pages:
ISBN-13: 9781931879392
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GAMP Good Practice Guide
Author:
Publisher: Ispe Headquarters
Published: 2005
Total Pages:
ISBN-13: 9781931879422
DOWNLOAD EBOOK →GAMP Good Practice Guide
GAMP 5
Author: Sion Wyn
Publisher:
Published: 2008
Total Pages: 0
ISBN-13: 9781931879613
DOWNLOAD EBOOK →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.
GAMP Good Practice Guide
Data Integrity and Data Governance
Author: R. D. McDowall
Publisher: Royal Society of Chemistry
Published: 2018-11-09
Total Pages: 660
ISBN-13: 178801281X
DOWNLOAD EBOOK →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.
Method Validation in Pharmaceutical Analysis
Author: Joachim Ermer
Publisher: John Wiley & Sons
Published: 2006-03-06
Total Pages: 418
ISBN-13: 3527604472
DOWNLOAD EBOOK →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.
Pharmaceutical Computer Systems Validation
Author: Guy Wingate
Publisher: CRC Press
Published: 2016-04-19
Total Pages: 773
ISBN-13: 1420088955
DOWNLOAD EBOOK →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.
ISPE GAMP® RDI Good Practice Guide
Author: Ispe
Publisher:
Published: 2019-06-07
Total Pages: 152
ISBN-13: 9781946964199
DOWNLOAD EBOOK →Good Research Practice in Non-Clinical Pharmacology and Biomedicine
Author: Anton Bespalov
Publisher: Springer Nature
Published: 2020-01-01
Total Pages: 424
ISBN-13: 3030336565
DOWNLOAD EBOOK →This open access book, published under a CC BY 4.0 license in the Pubmed indexed book series Handbook of Experimental Pharmacology, provides up-to-date information on best practice to improve experimental design and quality of research in non-clinical pharmacology and biomedicine.
