Established based on ICHQ7 requirements

Quality Systems: Four Layers of Support

Sophisticated Quality Control Document System

Quality System AreaWhat It Covers
Master Documents / Quality Manual / SOPsDocumentation hierarchy governing all GMP operations
Raw Material & Finished Product ReleaseTesting and release criteria ensuring every batch meets specification before use or shipment
Equipment Calibration & QualificationIQ/OQ/PQ protocols and routine calibration to maintain validated, audit-ready equipment 
Change ControlStructured review and approval process for any change affecting product quality or compliance
Deviation / OOS InvestigationRoot cause investigation and resolution for any deviation or out-of-specification result
Product Quality ReviewPeriodic trend analysis confirming consistent process performance and product quality
CAPA ManagementCAPA management — corrective and preventive action system closing the loop on quality issues
Training ProgramsDocumented, role-based training ensuring staff competency on GMP procedures