![ISPE GAMP® 5: A Risk-Based Approach to Compliant GxP Computerized Systems (Second Edition) [Japanese Translation] cover image](/cms/asset/a3afb26f-05bb-4cd3-8a2b-392357546f3e/9781946964823.cover.jpg)
ISPE GAMP® 5: A Risk-Based Approach to Compliant GxP Computerized Systems (Second Edition) [Japanese Translation]
Published:April 2025
Pages:410
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 G×P 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.
- Sam Andrews, Novartis, United Kingdom
- Karen Ashworth, Karen Ashworth Consulting Ltd., United Kingdom
- Carsten Bierans, Körber Pharma Software, Germany
- James Canterbury, Ernst and Young LLP, USA
- Mark Cherry, AstraZeneca, United Kingdom
- Chris Clark (Co-Lead), TenTenTen Consulting Limited, United Kingdom
- Stephen R. Ferrell, CompliancePath (an Ideagen Company), USA
- James Gannon, PharmaLedger Association, Ireland
- Senthil Gurumoorthi, Amazon, USA
- Robert Hahnraths, Bayer, Germany
- James Henderson, Eli Lilly and Company, USA
- Frank Henrichmann, QFINITY, Germany
- Oliver Herrmann, QFINITY, Germany
- David Samuel Holt, Factorytalk Co., Ltd., Thailand
- Paul Irving, Northern Life Sciences Ltd., United Kingdom
- Torsten Isenberg, Körber Pharma Software, Germany
- Paige Kane, PhD, Merck & Co., Inc., USA
- David Margetts, Factorytalk Co., Ltd., Thailand
- Andrew McDonagh, Emergn, United Kingdom
- Elizabeth McLellan, Suvoda, USA
- Sandy Meek, Parexel, United Kingdom
- Khaled Moussally, Compliance Group Inc., USA
- Ray Murphy, Boston Scientific, Ireland
- Mark E. Newton, Heartland QA, USA
- Donal O’Brien, Dassault Systèmes, Ireland
- Arthur D. Perez, PhD, Novartis (retired), USA
- Margrét Pétursdóttir, Alvotech, Iceland
- Rajdeep Poddar, Novartis Healthcare Pvt. Ltd., India
- Chris Reid, Integrity, United Kingdom
- Edgar Röder, PricewaterhouseCoopers, Germany
- Gregory Ruklic, GMR Consultants, USA
- Michael L. Rutherford, Syneos Health, USA
- Judith S. Samardelis, GSK, USA
- Levi Schenk, CSL Behring, USA
- Lorrie Vuolo-Schuessler, Syneos Health, USA
- Tanya Sharma, Assurea, LLC, USA
- Ken Shitamoto, Gilead, USA
- Eric J. Staib, Signant Health, USA
- Brandi M. Stockton, Signant Health, USA
- Thana Subramanian, Integrity, United Kingdom
- Charlie Wakeham, Waters Corporation, Australia
- Heather Watson (Co-Lead), GSK (retired), United Kingdom
- Christopher H. White, National Resilience, Inc., USA
- Tomos Gwyn Williams, Manchester Imaging, United Kingdom
- Guy Wingate, GSK (retired), United Kingdom
- Christian Wölbeling, Körber Pharma Software, Germany
- Sion Wyn (Co-Lead), Conformity Ltd., United Kingdom
The COVID-19 global pandemic underlined the essential role of innovation and technical advance in the protection of public health. This Second Edition of the ISPE GAMP® 5 Guide is intended to support such innovation and technical advance while safeguarding product quality and patient safety.
Such innovation is essential for life sciences industries in providing value to society while also controlling costs and reducing time to market.
Operating in a highly regulated industry may lead practitioners to apply prescriptive and rigid compliance-based approaches that are not commensurate with and not effective in managing any actual risk to the product and the patient.
This Guide facilitates the effective and efficient use of valuable resources by the application of appropriate and proportionate practices, encouraging innovative approaches to managing risk to patient safety, product quality, and data integrity, while supporting benefit to public health.