| Audit Item | Yes | No | Comments |
|---|---|---|---|
| Raw materials are correctly labeled and stored | |||
| Equipment is clean and maintained | |||
| Batch records are completed and signed | |||
| Environmental conditions meet specifications | |||
| Final products are properly tested and inspected | |||
| Personnel follow gowning and hygiene procedures | |||
| Proper segregation of materials and products | |||
| Appropriate labeling of status and quarantine areas | |||
| Deviations or issues are documented and investigated |