GAMP Good Practice Guide PDF Download
Are you looking for read ebook online? Search for your book and save it on your Kindle device, PC, phones or tablets. Download GAMP Good Practice Guide PDF full book. Access full book title GAMP Good Practice Guide by . Download full books in PDF and EPUB format.
Author:
Publisher: Ispe Headquarters
ISBN: 9781931879392
Category : Technology & Engineering
Languages : en
Pages :
Get Book Here
Book Description
Author:
Publisher: Ispe Headquarters
ISBN: 9781931879392
Category : Technology & Engineering
Languages : en
Pages :
Get Book Here
Book Description
Author:
Publisher: Ispe Headquarters
ISBN: 9781931879422
Category : Technology & Engineering
Languages : en
Pages :
Get Book Here
Book Description
Author: Sion Wyn
Publisher:
ISBN: 9781931879613
Category : Computer systems
Languages : en
Pages : 0
Get Book Here
Book Description
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: ISPE
Publisher:
ISBN: 9781931879255
Category : Technology & Engineering
Languages : en
Pages : 19
Get Book Here
Book Description
Author: Joachim Ermer
Publisher: John Wiley & Sons
ISBN: 3527604472
Category : Science
Languages : en
Pages : 418
Get Book Here
Book Description
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:
Publisher: Ispe
ISBN: 9781931879385
Category : Pharmaceutical industry
Languages : en
Pages :
Get Book Here
Book Description
Author:
Publisher:
ISBN: 9781931879569
Category : Pharmaceutical industry
Languages : en
Pages : 104
Get Book Here
Book Description
Author: R. D. McDowall
Publisher: Royal Society of Chemistry
ISBN: 178801281X
Category : Computers
Languages : en
Pages : 660
Get Book Here
Book Description
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: Ispe
Publisher:
ISBN: 9781946964144
Category :
Languages : en
Pages : 148
Get Book Here
Book Description
Author: International Society of Pharmaceutical Engineers
Publisher:
ISBN: 9781936379422
Category : Laboratories
Languages : en
Pages : 172
Get Book Here
Book Description
