Qualification Execution Checklist

Equipment: Hammer Mill

Subcategory: Solid Dosage Form (OSD)

Area: Production/Milling

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

Pre-start

Training completed
SOPs reviewed and approved
User Requirements Specification (URS) approved
Regulatory Approval (RA) obtained

Calibration/PM Status Verification

Calibration status verified
Preventive Maintenance (PM) completed

Protocol Readiness and Approvals

Protocol drafted
Protocol reviewed and approved

Execution Controls

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

Review and Approvals

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