Aseptic Filling (PFS/Vials) for LAI – 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 Ensure fill accuracy of depot suspension H DQ-001 IQ-001 OQ-001 PQ-001 Fill Accuracy Report
URS-002 Verify suspension homogeneity M DQ-002 IQ-002 OQ-002 PQ-002 Homogeneity Test Results
URS-003 Implement aseptic controls during filling H DQ-003 IQ-003 OQ-003 PQ-003 Aseptic Control Logs
URS-004 Maintain audit trail for filling operations M DQ-004 IQ-004 OQ-004 PQ-004 Audit Trail Documentation
See also  CCIT System (Vacuum Decay/Helium/HVLD) – OQ Protocol

Also Check:

Drying Oven / Drying Tunnel – DQ Protocol

Document Number: DQ-TP-001 Version: 1.0 Effective Date: 2023-10-01 Prepared by: [Name] Approved by: [Name] Design Qualification Protocol for Drying Oven/Drying Tunnel in Transdermal Patch Production Meta Description: This document outlines the Design Qualification Protocol for the Drying Oven/Drying Tunnel used…