Author: Publisher: Ispe Headquarters
ISBN: 9781931879422
Category : Technology & Engineering
Languages : en
Pages :
Book Description
GAMP Good Practice Guide
Author: Publisher: Ispe Headquarters
ISBN: 9781931879422
Category : Technology & Engineering
Languages : en
Pages :
Book Description
GAMP Good Practice Guide
Author: Publisher: Ispe Headquarters
ISBN: 9781931879392
Category : Technology & Engineering
Languages : en
Pages :
Book Description
GAMP 5
Author: Sion WynPublisher:
ISBN: 9781931879613
Category : Computer systems
Languages : en
Pages : 0
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.
GAMP Good Practice Guide
Author: ISPEPublisher:
ISBN: 9781931879255
Category : Technology & Engineering
Languages : en
Pages : 19
Book Description
Method Validation in Pharmaceutical Analysis
Author: Joachim ErmerPublisher: John Wiley & Sons
ISBN: 3527604472
Category : Science
Languages : en
Pages : 418
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.
ISPE Good Practice Guide
Author: Publisher:
ISBN: 9781931879569
Category : Pharmaceutical industry
Languages : en
Pages : 104
Book Description
GAMP Good Practice Guide
Author: Publisher: Ispe
ISBN: 9781931879385
Category : Pharmaceutical industry
Languages : en
Pages :
Book Description
ISPE GAMP® RDI Good Practice Guide
Author: IspeISPE Good Practice Guide
Author: IspeGAMP Good Practice Guide
Author: Publisher:
ISBN:
Category : Computer systems
Languages : en
Pages : 192
Book Description
This GAMP Good Practice Guide: A Risk-Based Approach to GxP Process Control Systems is a revision of the GAMP Good Practice Guide: Validation of Process Control Systems. It provides guidance and examples on the application of the principles and framework of GAMP 5: A Risk-Based Approach to Compliant GxP Computerized Systems to a wide range of systems, from basic instruments to large, complex, distributed control systems.This Guide aims to achieve process control systems that are fit for intended use and compliant with applicable regulations; providing recommended good practice based on a life cycle approach for the development, maintenance, and management of process control systems. The Guide applies science-based Quality Risk Management, as described in ICH Q9 and GAMP 5. It describes the system life cycle from concept to retirement, providing a high level overview of the approach together with guidance on how activities might be scaled based on risk to product quality, system novelty, and complexity as well as other project specific factors.