GAMP 5Good Automated Manufacturing Practice (v5)
GAMP 5 is ISPE's industry guide to a risk-based approach for GxP computerised systems; the current Second Edition was published in July 2022. It is good practice, not a law, regulation or certification.
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How does GAMP 5 apply to your shop floor?
Pick your industry and scale — Ask V5 rewrites the definition in your context, gives a worked example, and shows what V5 does on day one.
01What GAMP 5 is
GAMP 5 — full title 'A Risk-Based Approach to Compliant GxP Computerized Systems' — is published by ISPE, an industry association. ISPE describes its aim as a cost-effective framework of good practice so computerised systems are fit for intended use and compliant with applicable regulations.
Regulators do not certify against GAMP, and no software is 'GAMP 5 compliant' in a legal sense. Companies use it to plan how they will meet requirements such as EU GMP Annex 11, 21 CFR Part 11 or Part 820 software validation.
02What the Second Edition emphasises
According to ISPE's public description, the 2022 edition keeps the first edition's principles and updates them for:
- the larger role of service providers, encouraging regulated companies to use supplier knowledge and documentation where possible;
- iterative and incremental development, not only a linear specify-then-verify model;
- software tools and automation across the lifecycle;
- critical thinking by knowledgeable subject-matter experts;
- links to FDA's CSA approach and to data integrity guidance, with appendices on topics such as cloud, AI/ML and open-source software.
03Law, guidance and industry practice
| Document | Who issues it | Status |
|---|---|---|
| 21 CFR Part 11, Part 211, Part 820 | FDA | U.S. regulation |
| EU GMP Annex 11 | European Commission | EU GMP guideline |
| CSA guidance | FDA | Nonbinding guidance |
| GAMP 5 | ISPE | Industry good practice |
04Worked example
A company buying a configurable SaaS quality system uses GAMP thinking to plan validation: it assesses the supplier, reuses supplier test evidence where the assessment supports it, concentrates its own testing on configured workflows that affect product quality, and documents the reasoning. The plan cites Annex 11 and Part 11 as the requirements; GAMP explains the approach.
05Common failure modes and checks
- Citing GAMP 5 as a legal requirement in procedures or contracts.
- Accepting a vendor's 'GAMP compliant' claim as validation.
- Applying a heavy document template regardless of risk, which the Second Edition explicitly moves away from.
06Where V5 fits
Customers often apply GAMP-style supplier assessment to V5. Enterprise may include IQ/OQ documentation and validation support that a customer can evaluate as supplier evidence. The customer decides how GAMP applies, performs any PQ and approves its validated state.
Frequently asked questions
Q.Is GAMP 5 a regulation?+
No. It is an ISPE industry guide.
Q.When was the Second Edition published?+
July 2022, according to ISPE.
Q.Can software be GAMP 5 certified?+
No. There is no GAMP certification for software.
Q.Were GAMP software categories reviewed for this page?+
No. The guide is a paid publication and was not opened, so this page does not summarise its categories.
Primary sources
Further reading
Explore this topic
GAMP 5 sits inside 2 overlapping topic clusters in our glossary. Every neighbour is one click away.
Electronic records, signatures, audit trail and ALCOA+ data-integrity principles.
URS-through-PQ lifecycle, GAMP 5 categorisation and CSA's modern alternative.
Want to see how GAMP 5 could fit into your own records and workflows? Explore the related V5 pages or talk to our team about what applies to your operation.