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Checklist of Qualification and Control Documentation
The FDA, as per existing cGMP regulations and considers process validation necessary because it makes good engineering sense.
| Subpart | Subpart Section of CGMPs | Qualification and control documentation |
| A | General provisions | – |
| B | Organization and personnel | Responsibilities of the quality control unit |
| C | Buildings and facilities | Plant and facility installation and qualification
Maintenance and sanitation Microbial and pest control |
| D | Equipment | Installation and qualification of equipment and cleaning methods |
| E | Control of components, containers and closures | Incoming component testing procedures |
| F | Production and process controls | Process control systems, reprocessing control of microbial contamination |
| G | Packaging and labeling controls | Dehydrogenation, sterile packaging, filling and closing, expire dating |
| H | Holding and distribution | Warehousing and distribution procedures |
| I | Laboratory controls | Analytical methods, testing for release
component testing and stability testing |
| J | Records and reports | Computer systems and information systems |
| K | Return and salvaged drug products | Batch reprocessing |
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