# GAMP

> GAMP, short for Good Automated Manufacturing Practice, is guidance published by ISPE on a risk-based approach to computerised systems in GxP environments.

Original page: https://t10.de/en/glossary/gamp
Publisher: total10 GmbH, https://t10.de/en/glossary

According to the PIC/S guidance document PI 011-3, the Pharmaceutical Industry Systems Validation Forum in the UK developed the GAMP Supplier Guide to help software suppliers implement an appropriate quality management system. GAMP is one of ISPE's Communities of Practice. The [ISPE GAMP 5 Guide, Second Edition](https://ispe.org/publications/guidance-documents/gamp-5-guide-2nd-edition), is titled 'A Risk-Based Approach to Compliant GxP Computerized Systems'. In ISPE's words, it maintains the principles and framework of the first edition and updates their application.

ISPE says GAMP aims to deliver a framework of good practice to ensure that computerised systems are effective and of high quality, fit for intended use and compliant with applicable regulations. It describes the approach as patient-centric and risk-based. ISPE's page '[What is GAMP?](https://ispe.org/initiatives/regulatory/what-gamp)' adds that GAMP does not define a prescriptive method or a standard, but provides pragmatic guidance, approaches and tools for the practitioner. GAMP is industry guidance, not law.

For the systems we build (see Non-GxP), we give the operator's QA team something concrete to check: automated tests, security testing and traceability matched to the system's purpose. For traceability, for example, a change history shows each logged change, who made it and when.

## See also

- [GxP](https://t10.de/en/glossary/gxp): GxP is an umbrella term for the good practice guides and requirements of the regulated pharmaceutical sector, such as good manufacturing practice (GMP) and good distribution practice (GDP).
- [Validation](https://t10.de/en/glossary/validation): In the EU GMP and GDP glossaries, validation is the action of proving that any procedure, process, equipment, material, activity or system actually leads to the expected results.

## Where the term appears

- [Non-GxP in pharma: what we build, what we leave out and where our systems stop](https://t10.de/en/blog/non-gxp-pharma-logistics)
- [Pharma IT services: Non-GxP software](https://t10.de/en/pharma)

## Sources

1. [PI 011-3 Good Practices for Computerised Systems in Regulated GxP Environments (25. September 2007)](https://picscheme.org/docview/3444), PIC/S, accessed 2026-11-06
2. [ISPE GAMP 5 Guide: A Risk-Based Approach to Compliant GxP Computerized Systems (Second Edition)](https://ispe.org/publications/guidance-documents/gamp-5-guide-2nd-edition), ISPE, accessed 2026-11-06
3. [What is GAMP?](https://ispe.org/initiatives/regulatory/what-gamp), ISPE, accessed 2026-11-06