Validation

Good Automated Manufacturing Practice (GAMP) 5

This document is a guideline, used widely within FDA-regulated industries, for validation of computer systems. ISPE and the GAMP Forum produce the GAMP Guide.

(http://www.ispe.org/gamp/)

General Principles of Software Validation; Final Guidance for Industry and FDA Staff (January 11, 2002)

This guidance presents principles of software validation considered to be applicable by the FDA.

(http://www.fda.gov/cdrh/comp/guidance/938.html)

Pharmaceutical cGMPs for the 21st Century: A Risk-Based Approach; A Science and Risk-based Approach to Product Quality Regulation Incorporating an Integrated Quality Systems Approach (2002)

This describes the FDA's review of cGMPs and defines specific immediate, intermediate, and long term steps for the FDA's review.

(http://www.fda.gov/oc/guidance/gmp.html)