| Quality |
Assures overall compliance with cGMPs and internal procedures and specifications |
- Section 2, Quality Management
- Section 3, Personnel
- Section 6, Documentation and Records
- Section 13, Change Control
- Section 14, Rejection and Reuse of Materials
- Section 15, Complaints and Recalls
- Section 16, Contract Manufacturers (including laboratories)
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- Deviation Procedure and list
- CAPAs (corrective and preventative action)
- OOS issued list
- Investigation Procedure
- Change Control Procedure and List
- Equipment
- Customer Notification
- Compliant/Recalls
- Quality Manual
- Annual Product review
- Training
- Internal/External Audit Schedule
- Organizational Chart
- Job Description
- Documentation- SOPs
- GMP Manufacturing
- SOP Index
- Stability data/Reports
- FDA Registration/Inspection Report
- Supplier Approval Program
- Service Provider Approval Program
- Instrument Calibration
- Method Validation
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| Facilities & Equipment |
Includes activities which provide an appropriate physical environment and resources used in production |
- Section 3, Personnel
- Section 4, Buildings and Facilities
- Section 5, Process Equipment
- Section 6, Documentation and Records
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- Master Validation Plan
- Equipment Preventative Maintenance
- Equipment Calibration
- Equipment Cleaning
- Equipment Qualification
- Building/Facility Management
- HVAC System
- Air/Water
- Pest Control
- Environmental Monitoring
- Subcontracting Policy
- Facility Tour
- Waste Handling
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| Materials |
Includes measures and activities to control starting materials, intermediates, and containers. It includes validation of computerized and inventory control processes, storage and distribution controls |
- Section 3, Personnel
- Section 4.3, Water
- Section 6, Documentation and Records
- Section 7, Materials Management
- Section 10, Storage and Distribution
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- Materials Management and Material control
- Raw Material Receipt and Approval
- BSE/TSE
- Rejected Material
- Cross Contamination
- Material flow/personnel
- Animal Origin/ Use of derived materials
- Shelf Life Validation
- Inventory management
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| Production |
Includes measures and activities to control the manufacture of materials, including in-process sampling and testing, and process validation. |
- Section 3, Personnel
- Section 6, Documentation and Records
- Section 8, Production and In-process Controls
- Section 12, Validation
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- Batch Records (Issue/review/release)
- Process Logbooks
- Packaging and labeling
- Cleaning Procedures
- Gowning Requirements
- Equipment Calibration
- Process Validation for specific product
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