Qualification Execution Checklist

Equipment: Cartoning Machine

Subcategory: Solid Dosage Form (OSD)

Area: Packaging/Secondary

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

CSV Required: Yes

Pre-start

Training completed
SOPs reviewed and approved
URS approved
RA approved

Calibration/PM Status Verification

Calibration status verified
Preventive Maintenance (PM) completed

Protocol Readiness and Approvals

Protocol finalized
Approvals obtained from all relevant stakeholders

Execution Controls

Good Documentation Practices (GDP) followed
Data recording procedures in place
Deviations documented

Review and Approvals

Engineering review completed
Validation review completed
QA review completed