Qualification Execution Checklist

Equipment: Patch Leak Test Machine

Subcategory: Transdermal Patches (TDS)

Area: Production/QC

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

CSV Required: Yes

Pre-start Checks

Training completed
SOPs reviewed
URS approved
RA approved

Calibration/PM Status Verification

Calibration status verified
PM status verified

Protocol Readiness and Approvals

Protocol finalized
Approvals obtained

Execution Controls

GDP followed
Data recorded accurately
Deviations documented

Review and Approvals

Engineering review completed
Validation review completed
QA approval obtained

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