Issue link: https://www.e-digitaleditions.com/i/1199406
28 January 2020 Tablets & Capsules Comprehensive equipment and utility change control for GMP production facilities A Greg Weilersbacher EAS Consulting Group good manufacturing practices This article provides a systematic process for designing util- ity change control procedures for new equipment in GMP production facilities. nnex 15 of the "EU Guidelines for Good Manufac- turing Practice for Medicinal Products for Human and Veterinary Use" defines "change control" as: "A formal system by which qualified representatives of appropriate disciplines review proposed or actual changes that might affect the validated status of facilities, systems, equip- ment or processes" [1]. The FDA's own guidances refer to change control as "…managing change to prevent unin- tended consequences" [2].