In-vitro Release Testing System (Dialysis/Flow-through/USP apparatus as applicable) – Qualification Execution Checklist

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




Calibration/PM Status Verification


Protocol Readiness and Approvals



Execution Controls



Review and Approvals



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Also Check:

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