GAMP Good Practice Guides

GAMP 5: A Risk-Based Approach to Compliant GxP Computerized Systems provides pragmatic and practical industry guidance that aims to achieve compliant computerized systems that are fit for intended use in an efficient and effective manner, while also enabling innovation and technological advances.
Reflecting current regulatory expectations and good practices for automated/computerized systems, the GAMP series of Good Practice Guides help to narrow interpretation of regulatory standards for improved compliance and quality, efficiency, and cost reductions. They typically focus on the “how”.

Language
English
Guidance Docs
The drive within life sciences to improve patient safety and product quality, and provide value to society, while reducing costs requires constant and effective innovation. However, because the pharmaceutical industry operates in a highly regulated sector, some practitioners may apply unthinking, prescriptive, and rigid approaches that are not commensurate to the needs of the process, the nature of the system, and the real risk to the product and the patient.
Guidance Docs
This Guide helps the reader to maximize testing efficiency without compromising the quality of GxP Systems by focusing testing on areas that have the greatest impact and eliminating duplicate testing. This GAMP Good Practice Guide conforms to GAMP® 5 standards and terminology and reflects ICH Q8, Q9, and Q10, Quality by Design, and Process Analytical Technology principles.
Guidance Docs
This ISPE GAMP® RDI Good Practice Guide: Data Integrity by Design supports organizations as they embrace and implement a holistic approach by leveraging data governance and knowledge management activities to drive continual improvement in data integrity.
Guidance Docs
Published: October 2014 Pages: 96 Table of Contents Special Pricing for Emerging Economies More than 3 billion people worldwide use a smartphone and according to industry estimates almost 60% of those users will download a mobile health application
Guidance Docs
The ISPE GAMP® RDI Good Practice Guide: Data Integrity – Manufacturing Records provides practical and pragmatic advice on areas such as regulated records, data flows, and risk management approaches, with particular focus on process control systems, manufacturing execution systems, and the interfaces and relationship between them.
Guidance Docs
The ISPE GAMP® RDI Good Practice Guide: Data Integrity – Key Concepts provides detailed practical guidance to support data integrity within a regulated organization. In recent years significant problems with data integrity have been found in the pharmaceutical, biotechnology, and medical device industries worldwide. This ultimately affects patients, as patient safety is intrinsically impacted by the integrity and quality of the data on which a regulatory decision is based.
Guidance Docs
Published: December 2017 Pages: 128 Table of Contents Special Pricing for Emerging Economies The ISPE GAMP® Good Practice Guide: Validation and Compliance of Computerized GCP Systems and Data (Good eClinical Practice) is intended to provide a risk
Guidance Docs
Published: August 2017 Pages: 168 Table of Contents Special Pricing for Emerging Economies The ISPE GAMP® Good Practice Guide: IT Infrastructure Control and Compliance (Second Edition) is intended to provide comprehensive guidance on meeting
Guidance Docs
Published: October 2012 Pages: 160 Table of Contents Special Pricing for Emerging Economies Recently updated to conform with GAMP® 5 concepts and terminology, as well as recent regulatory and industry developments, the ISPE GAMP® Good Practice Guide
Guidance Docs
Published: November 2010 Pages: 124 Table of Contents Special Pricing for Emerging Economies The GAMP® Good Practice Guide: A Risk-Based Approach to Calibration Management (Second Edition) provides guidance in setting up a calibration management