Qualification Execution Checklist

Equipment: Oscillating Granulator

Subcategory: Solid Dosage Form (OSD)

Area: Production/Milling

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

Pre-start

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

Calibration/PM Status Verification

Calibration status verified
Preventive Maintenance (PM) completed

Protocol Readiness and Approvals

Protocol ready for execution
Protocol approved by all parties

Execution Controls

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

Review and Approvals

Engineering review completed
Validation review completed
Quality Assurance (QA) review completed

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