Fitz Mill / Comminuting Mill – Qualification Execution Checklist

Qualification Execution Checklist

Equipment: Fitz Mill / Comminuting Mill

Subcategory: Solid Dosage Form (OSD)

Area: Production/Milling

DQ/IQ/OQ/PQ: Yes/Yes/Yes/Yes
Pre-start Checks





Calibration/PM Status Verification



Protocol Readiness and Approvals





Execution Controls




Review and Approvals




See also  Ophthalmic Filling Machine (Dropper Bottles) – Deviation Impact Assessment

Also Check:

Air Classifier Mill – Traceability Matrix (URS ↔ Tests)

URS ID URS Statement Risk (H/M/L) DQ Test Ref IQ Test Ref OQ Test Ref PQ Test Ref Evidence/Record Result URS-001 Air Classifier Mill must achieve specified particle size distribution (PSD). H DQ-001 IQ-001 OQ-001 PQ-001 Test Report 001 URS-002…

Isolator / RABS (NDDS Filling) – Deviation Impact Assessment

Deviation Impact Assessment Template Equipment Details Equipment: Isolator / RABS (NDDS Filling) Area: Production Criticality: Critical Product Impact: Direct CSV Required: Yes Deviation Details Description of Deviation: [Insert detailed description of the deviation] Date of Deviation: [Insert date] Reported By:…