Qualification Execution Checklist

Equipment: Drum Tippler/Drum Tumbler

Subcategory: Solid Dosage Form (OSD)

Area: Production/Dispensing

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

Pre-start Checks

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

Calibration/PM Status Verification

Calibration status verified
Preventive Maintenance (PM) status verified

Protocol Readiness and Approvals

Protocol prepared and reviewed
Protocol approved by Engineering
Protocol approved by Validation
Protocol approved by QA

Execution Controls

Good Documentation Practices (GDP) followed
Data recording completed
Deviations documented and addressed

Review and Approvals

Review completed by Engineering
Review completed by Validation
Review completed by QA

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