Qualification Execution Checklist

Equipment: High Shear Mixer / Homogenizer

Subcategory: Transdermal Patches (TDS)

Area: Production

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

CSV Required: Yes

Pre-start

Staff Training Completed
SOPs Reviewed and Approved
User Requirements Specification (URS) Approved
Regulatory Approval (RA) Received

Calibration/PM Status Verification

Calibration Status Verified
Preventive Maintenance (PM) Status Verified

Protocol Readiness and Approvals

Qualification Protocol Prepared
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

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