General Controls
Organizational & Management Responsibilities
Document Control Program
Employee Orientation, Quality Awareness, and Job Training
Plant Safety and Security
Internal Quality/GMP Audit Program
Quality Cost Program
Facility Control
Facility Design and Layout
Environmental Control Program
Facility Maintenance and Good Housekeeping Program
Outside Contractor Control Program
Equipment Design and Placement
Design and Placement
Equipment Identification
Equipment Maintenance & Cleaning
Measurement Equipment Calibration Program
Equipment Qualification Program
Material/ Component Control
Material/Component Specification and Purchasing Control
Material/Component Receipt, Inspection, Sampling, and Laboratory Testing
Material Component Storage and Handling
Inventory Control Program
Vendor (Supplier) Control Program
Operational Control
Material/Component/Label Verification, Storage, and Handling
Equipment/Line/Area Cleaning, Preparation, and Clearance
Operational Process Validation and Production Change Order Control
In-Process Inspection, Sampling, and Laboratory Control
Reprocessing/Disposition of Materials
Finished Product Control
Finished Product Verification, Storage, and Handling
Finished Product Inspection, Sampling, Testing, and Release for Distribution
Distribution Controls
Marketing Controls
Complaint Handling and Customer Satisfaction Program
Completion