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GAMP 5 Second Edition: Risk-Based Approach to Compliant GxP Systems

Software categorization (Category 1 to 5), the V-Model, and agile integration in life sciences.

Executive Overview

GAMP 5 (Good Automated Manufacturing Practice) is the definitive global technical guideline for validating automated systems in pharmaceutical, biotechnology, and medical device manufacturing.

1. The GAMP 5 Software Categories

GAMP 5 categorizes software into four active categories (Category 2 was deprecated):

  • Category 1 (Infrastructure Software): Operating systems, databases, network operating systems, and virtualization layers.
  • Category 3 (Non-Configured Products): Out-of-the-box COTS tools used as-is without configuration.
  • Category 4 (Configured Products): Commercial platforms configured to match business processes (e.g., LIMS, ERP, MES, eQMS).
  • Category 5 (Custom Software): Bespoke software written from scratch for specific organizational needs, requiring full V-Model lifecycle verification.

Frequently Asked Questions

Can Agile software development be used under GAMP 5?

Yes; GAMP 5 Second Edition explicitly endorses Agile, continuous integration, and automated testing provided iterative traceability is maintained.

AI Summary

GAMP 5 (Good Automated Manufacturing Practice) is the definitive global technical guideline for validating automated systems in pharmaceutical, biotechnology, and medical device manufacturing.