Qualification Execution Checklist for CIP System

Area: Production

Subcategory: Transdermal Patches (TDS)

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

CSV Required: Yes

Pre-start

Training completed
SOPs reviewed and approved
URS approved
RA approved

Calibration/PM Status Verification

Calibration records verified
Preventive maintenance status confirmed

Protocol Readiness and Approvals

Protocol completed and approved
All necessary documentation in place

Execution Controls

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

Review and Approvals

Engineering review completed
Validation review completed
QA review completed