Pharmaceutical guides

GAMP 5 explained

A practical introduction to GAMP 5 and what it means for regulated ERP projects.

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What GAMP 5 is

GAMP 5 is guidance published by ISPE (the International Society for Pharmaceutical Engineering) on how to approach computerised systems in GxP-regulated environments. A second edition was published in 2022.

Its core idea is a risk-based approach: focus validation effort on what could affect patient safety, product quality and data integrity, rather than testing everything to the same depth.

GAMP 5 also groups software into categories, which helps decide how much verification is needed. An ERP is typically configured standard software, with any custom extensions needing more scrutiny.

Key ideas in GAMP 5

The principles most relevant to an ERP implementation.

Risk-based approach

Effort proportional to risk to patients, product and data.

Software categories

Infrastructure, non-configured, configured and custom software.

Life cycle

Planning, specification, verification and operation.

Supplier involvement

Use supplier documentation where it is reliable.

Critical thinking

Avoid documentation for its own sake.

Data integrity

Records must be complete, accurate and attributable.

Useful next reads

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FAQ

Frequently asked questions

Good Automated Manufacturing Practice.

No. It is industry guidance, but regulators widely recognise it as good practice for meeting GxP requirements for computerised systems.

Category 1 infrastructure software, category 3 non-configured products, category 4 configured products and category 5 custom applications. Category 2 was removed in GAMP 5.

Business Central is generally treated as configured software, with any custom extensions assessed separately. The validation approach should be agreed with your quality team.

Pharmaceutical and life sciences ERP