Qualification Execution Checklist for Pass Box (Dynamic with HEPA)
Equipment Information
Subcategory: Solid Dosage Form (OSD)
Area: Facility
DQ/IQ/OQ/PQ: Yes/Yes/Yes/Yes
CSV Required: Yes
Pre-start
- Training completed
- SOPs reviewed and approved
- URS approved
- Risk Assessment approved
Calibration/PM Status Verification
- Calibration status verified
- Preventive Maintenance status verified
Protocol Readiness and Approvals
- Protocol drafted
- Protocol reviewed
- Protocol approved
Execution Controls
- Good Documentation Practices (GDP) followed
- Data recording verified
- Deviations documented
Review and Approvals
- Engineering review completed
- Validation review completed
- QA approval obtained