Tangential Flow Filtration (TFF) System – 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 TMP is maintained within specified limits during operation. H DQ-001 IQ-001 OQ-001 PQ-001 TMP Log [Pass/Fail]
URS-002 Verify flow rates meet operational requirements. M DQ-002 IQ-002 OQ-002 PQ-002 Flow Rate Record [Pass/Fail]
URS-003 Confirm membrane integrity before and after use. H DQ-003 IQ-003 OQ-003 PQ-003 Membrane Integrity Test Report [Pass/Fail]
URS-004 Ensure temperature remains within specified limits during operation. M DQ-004 IQ-004 OQ-004 PQ-004 Temperature Log [Pass/Fail]
URS-005 Audit trail must be maintained for all critical parameters. L DQ-005 IQ-005 OQ-005 PQ-005 Audit Trail Record [Pass/Fail]
See also  Cooling Tunnel / Cooling Conveyor – IQ Protocol

Also Check:

V Blender – Validation Summary Report (VSR) Template

Validation Summary Report (VSR) Equipment: V Blender Subcategory: Solid Dosage Form (OSD) Area: Production/Blending Summary This Validation Summary Report outlines the validation activities performed for the V Blender used in the production of solid dosage forms. It includes details on…

IV Bag Form-Fill-Seal (FFS) Machine – Deviation Impact Assessment

Deviation Impact Assessment Equipment Details Equipment: IV Bag Form-Fill-Seal (FFS) Machine 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] Classification Deviation Classification:…

Inline Sifter (Transfer Line) – DQ Protocol

Design Qualification Protocol for Inline Sifter Equipment in Solid Dosage Form Production Document Control Number: DQ-OSD-001 Version: 1.0 Date of Issue: 2023-10-01 Reviewed by: [Name] Approved by: [Name] Objective The objective of this Design Qualification (DQ) Protocol is to establish…