Qualification Execution Checklist: Dispensing Booth (Downflow)

Area: Production/Dispensing

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

Pre-start Checks

Training completed
SOPs reviewed and approved
User Requirements Specification (URS) approved
Risk Assessment (RA) approved

Calibration/PM Status Verification

Calibration status verified
Preventive Maintenance (PM) status verified

Protocol Readiness and Approvals

Qualification Protocol drafted
Protocol approved by Engineering
Protocol approved by Validation
Protocol approved by QA

Execution Controls

Good Documentation Practices (GDP) followed
Data recording procedures adhered to
Deviations documented and managed

Review and Approvals

Engineering review completed
Validation review completed
QA review completed