Slitting Machine – Qualification Execution Checklist

Qualification Execution Checklist

Equipment: Slitting Machine

Subcategory: Transdermal Patches (TDS)

Area: Production

DQ/IQ/OQ/PQ: 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 records reviewed

Protocol Readiness and Approvals

Protocol drafted
Protocol approved by Engineering
Protocol approved by Validation
Protocol approved by QA

Execution Controls

Good Documentation Practices (GDP) followed
Data recording procedures followed
Deviations documented and reviewed

Review and Approvals

Engineering review completed
Validation review completed
QA review completed