What is GAMP®?

GAMP logo

GAMP® guidance aims to safeguard patient safety, product quality, and data integrity in the use of GxP computerized systems. It aims to achieve computerized systems that are fit for intended use and meet current regulatory requirements by building upon existing industry good practice in an efficient and effective manner.  GAMP® adopts a patient-centric risk-based approach that enables innovation while demonstrating compliance with regulatory requirements. GAMP® is an ISPE Community of Practice (CoP).

GAMP® provides practical guidance that:

  • Facilitates the interpretation of regulatory requirements
  • Establishes a common language and terminology
  • Promotes a system life cycle approach based on good practice
  • Clarifies roles and responsibilities

GAMP® guidance does not define a prescriptive method or a standard, but rather provides pragmatic guidance, approaches, and tools for the practitioner.

The ISPE GAMP® 5 Guide: A Risk-Based Approach to Compliant GxP Computerized Systems Second Edition aims to protect patient safety, product quality, and data integrity by facilitating and encouraging the achievement of computerized systems that are effective, reliable, and of high quality.  Technological innovation is essential for life sciences industries in providing value to society while also controlling costs and reducing time to market. The 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.

GAMP® 5 Guide, 2nd Edition: Top Takeaways

Explore GAMP® Hot Topics in 3 Questions

GAMP® RDI Good Practice Guide: Data Integrity – Key Concepts

Training Options

In-Person and Online Live

On Demand Training

Learn more about ISPE's Custom Training

GAMP® Guidance Documents

Good Automated Manufacturing Practice (GAMP®), is a technical sub-committee of the International Society for Pharmaceutical Engineering (ISPE). The goal of this committee is to promote the understanding of the regulation and use of automated systems within the pharmaceutical industry. The GAMP committee organizes training guides for its members. These guidelines are:

Pharmaceutical Engineering®  Magazine Articles

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Concept & Discussion Papers

Communities of Practice

As an ISPE Member, join an ISPE community of practice to participate in discussions on specific topics with your peers. Learn more about Communities of Practice.


Other Resources

ISPE GAMP® Global Leadership

Heather D. Watson
TenTenTen Consulting Ltd
Chair, GAMP® Global Steering Committee
Charlie C. Wakeham
Global Head of Quality and Compliance
Co-Chair, GAMP® Global Steering Committee
Frank Henrichmann
Sr. Exec. Consultant
Secretary, GAMP® Global Steering Committee
Chris Clark
TenTenTen Consulting Limited
Chair, GAMP® Editorial Review Board
Sion Wyn
Conformity Ltd.
ISPE Technical Consultant