How many controls does GAMP 5 have?

GAMP 5 contains 34 controls organized across 5 domains.

Where does GAMP 5 apply?

GAMP 5 is applicable in International. Organizations operating in or serving customers in this jurisdiction should evaluate its requirements.

What frameworks does GAMP 5 map to?

GAMP 5 has control-to-control mappings with 561 other compliance frameworks in our database. Use our compliance platform to explore these mappings interactively.

How do I get started with GAMP 5 compliance?

Start by understanding the framework's key controls and domains. Our compliance platform provides AI-powered gap analysis and mapping tools to help you assess your current posture and build a remediation plan.

GAMP 5 — Good Automated Manufacturing Practice

GAMP 5 (Good Automated Manufacturing Practice Guide, 2nd Edition 2022) is an ISPE guidance document providing a risk-based approach to the validation of computerized systems in the pharmaceutical and healthcare industries. It aligns with regulatory expectations from FDA, EMA, and other agencies.

Domains

Modern Technologies

Operational Phase

Lifecycle Approach (V-Model)

Software Categories

Risk Management

Frequently Asked Questions

Map GAMP 5 — Good Automated Manufacturing Practice to any other framework

Use our AI-powered compliance platform to find control overlaps, gaps, and build remediation plans in seconds.

Try Free on Compliance Platform