GAMP 5 Guide 2nd Edition

Digital Only

Member Price
$395.00
Non-Member Price
$695.00

Published: July 2022
Pages: 404

GAMP aims to deliver a cost-effective framework of good practice to ensure that computerized systems are effective and of high quality, fit for intended use, and compliant with applicable regulations.

Maintaining the principles and framework of the first edition, ISPE GAMP® 5: A Risk-Based Approach to Compliant GxP Computerized Systems (Second Edition) updates their application in the modern world including the increased importance of service providers, evolving approaches to software development, and expanded use of software tools and automation. It highlights the use of critical thinking by knowledgeable and experienced SMEs to define appropriate approaches.

The ISPE GAMP Community of Practice (CoP) performs regular ongoing assessments and reviews of GAMP knowledge against current practices and regulatory and technology developments. ISPE GAMP 5 Second Edition therefore embraces and reflects:

  • Increased importance of service providers, which includes encouraging regulated companies to maximize supplier involvement to leverage knowledge, experience, and documentation where possible
  • Evolving approaches to software development, emphasizing that the GAMP specification and verification approach is not inherently linear but also fully supports iterative and incremental methods
  • Increased use of software tools and automation to achieve greater control, higher quality, and lower risks throughout the life cycle

Furthermore, this Guide highlights the importance of applying “critical thinking” by knowledgeable and experienced SMEs when defining the appropriate approach for specific circumstances.

Discussion of current FDA activity on Computer Software Assurance (CSA) approaches and clear links to ISPE/GAMP guidance on Data Integrity (DI) have been added.

The Appendices have been expanded to incorporate new and evolving topics in the life sciences industry such as blockchain, Artificial Intelligence/Machine Learning (AI/ML), cloud computing, and Open-Source Software (OSS).

This Guide is intended for use by regulated companies, suppliers, and regulators. Suppliers include providers of software, hardware, equipment, system integration services, IT service providers, and IT support services, both internal and external to the regulated company.


Guide Core Team

Chris Clark
Director
TenTenTen Consulting
Co-Lead
Heather D. Watson
Company Director and Consultant
TenTenTen Consulting Limited
Co-Lead
Sion Wyn
Director
Conformity Ltd.
Co-Lead
James Canterbury
Principal, Consulting
Ernst & Young LLP
Mark R. Cherry
IT Compliance Director
AstraZeneca
Frank Henrichmann
Senior Executive Consultant
QFINITY Quality Management
Paul J. Irving, BSc Hons
Managing Director
Northern Life Sciences Ltd.
Arthur D. Perez, PhD
Retired Director Information Governance and Management
Novartis Pharmaceuticals
Christopher J. Reid
CEO
Integrity Project Solutions Limited
Michael L. Rutherford
Executive Director, Computer Systems Quality & Data Integrity
Syneos Health
Lorrie L. Vuolo-Schuessler
Senior Director Computer Systems Quality and Data Integrity
Syneos Health
Eric J. Staib
Vice President of Compliance & Quality Management
Signant Health
Placeholder Person Graphic
Thanabalan Subramanian
Head of Quality
Integrity
Charlie C. Wakeham
APAC GxP Compliance Manager
Waters Corporation
Christopher H. White
Senior Director, Digital Quality, Head of Digital Technology & Platforms
National Resilience, Inc.
Guy Wingate, PhD
Head of Transformation Office, Sustainability
GlaxoSmithKline PLC