Qualification Execution Checklist

Equipment: In-vitro Release Testing System (Dialysis/Flow-through/USP apparatus)

Subcategory: NDDS – Critical NDDS Analytics (CQA/CPP)

Area: QC/R&D

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

CSV Required: Yes

Pre-start

Training completed
SOPs approved
URS approved
RA approved

Calibration/PM Status Verification

Calibration records reviewed
PM status verified

Protocol Readiness and Approvals

Protocol drafted
Protocol reviewed
Protocol approved

Execution Controls

GDP compliance verified
Data recording procedures followed
Deviations documented

Review and Approvals

Engineering review completed
Validation review completed
QA review completed

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