This service provides independent assessment and, where applicable, certification of manufacturing operations against recognized GMP requirements, focusing on process control, hygiene, documentation, personnel practices, and product integrity.
GMP activities typically include review of facility layout and conditions, process controls, raw material handling, production and quality control practices, sanitation and hygiene measures, equipment maintenance, documentation and recordkeeping, training, and internal controls. Audit conclusions are based on objective evidence, documented observations, and applicable GMP criteria.
The service may be delivered as a gap assessment, compliance audit, or certification audit, depending on the applicable GMP scheme and client requirements.
