Qualification Execution Checklist for Bottle Unscrambler

Equipment: Bottle Unscrambler

Subcategory: Solid Dosage Form (OSD)

Area: Packaging/Primary

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

Pre-start

Training completed
SOPs reviewed and available
URS approved
RA approved

Calibration/PM Status Verification

Calibration records verified
Preventive Maintenance (PM) completed

Protocol Readiness and Approvals

Protocol drafted
Protocol reviewed
Protocol approved

Execution Controls

Good Documentation Practices (GDP) followed
Data recorded accurately
Deviations documented

Review and Approvals

Engineering review completed
Validation review completed
QA review completed