Nasal/Otic Compounding Vessel Qualification Execution Checklist

Equipment Details

Equipment: Nasal/Otic Compounding Vessel (Jacketed SS)

Subcategory: Nasal & Otic Products (Sterile / Non-Sterile)

Area: Production

DQ/IQ/OQ/PQ Flags: Yes / Yes / Yes / Yes

CSV Required: Yes

Pre-Start Checks

• Training completed
• SOPs approved
• URS approved
• RA approved

Calibration/PM Status Verification

• Calibration status verified
• PM status verified

Protocol Readiness and Approvals

• Protocol ready for execution
• All approvals obtained

Execution Controls

• Good Documentation Practices followed
• Data recording procedures in place
• Deviation management procedures established

Review and Approvals

• Engineering review completed
• Validation review completed
• QA review completed