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GAMP 5 (Good Automated Manufacturing Practice)

Definition

GAMP 5 is an ISPE (International Society for Pharmaceutical Engineering) guidance framework for the risk-based validation of automated and computerized systems used in GxP-regulated environments. It provides a structured approach to categorizing software and scaling validation effort according to system complexity and risk.

Benefits

Applying GAMP 5's risk-based categorization prevents organizations from over-validating low-risk, off-the-shelf functionality while ensuring high-risk, custom-configured features, like automated batch calculations, receive appropriately rigorous testing.

Use Case

A company implementing a new EBR system uses GAMP 5's software categorization framework to classify the platform's core functionality as a configured, non-custom system, scoping validation testing accordingly rather than applying the more intensive testing required for fully custom-built software.

Frequently Asked Questions (FAQ)

  • GAMP 5 is industry guidance, not a formal regulation, but it's widely recognized and referenced by regulators as an accepted approach to risk-based computerized system validation.

  • CSA builds on and aligns with GAMP 5's risk-based philosophy, pushing it further toward minimizing low-value scripted documentation in favor of critical-thinking-based testing for genuinely high-risk functionality.

Related Terms

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