Qualification Execution Checklist

Equipment: Laminator / Backing Attachment Unit

Subcategory: NDDS – Transdermal Microneedles / Advanced Patches

Area: Production

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 status verified
PM schedule adhered to

Protocol Readiness and Approvals

Protocol drafted
Protocol approved

Execution Controls

GDP practices followed
Data recorded accurately
Deviations documented

Review and Approvals

Engineering review completed
Validation review completed
QA approval obtained