The Global CAPA program applies to all corporate manufacturing facilities, research laboratories, and distribution centers operating under GxP regulations, specifically governing Global Quality Events which include events impacting multiple geographic regions or sites, Class I or Class II product recalls, critical audit findings from Regulatory Agencies, and systemic failures in the global Quality Management System.

This Standard applies to all corporate manufacturing facilities, research laboratories, and distribution centers operating under GxP regulations. It specifically governs 'Global Quality Events,' which are defined as: Events impacting multiple geographic regions or sites. Events resulting in Class I or Class II product recalls, Critical audit findings from Regulatory Agencies (FDA, EMA, MHRA), Systemic failures in the global Quality Management System (QMS).

legacy import — synthesised from supporting_context_primary