traceability matrix – Page 11

Drying Oven / Drying Tunnel – 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 ID 1] The drying oven must maintain a consistent temperature throughout the drying process. [H/M/L] [DQ Test Ref 1]…

Sterile Holding Tank – 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_ID_1] The Sterile Holding Tank must maintain pressure to ensure integrity of sterile product. [H/M/L] [DQ_Test_Ref_1] [IQ_Test_Ref_1] [OQ_Test_Ref_1] [PQ_Test_Ref_1] [Evidence_Record_1]…

High Pressure Homogenizer / Microfluidizer – 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 ID 1] The equipment must achieve specified pressure for effective size reduction. [H/M/L] [DQ Test Ref 1] [IQ Test…

Bag Washing / Blow-off Station (if used) – 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 ID] The Bag Washing / Blow-off Station must effectively remove particulates from bags. [H/M/L] [DQ Test Ref] [IQ Test…

Cooling Tunnel / Cooling Conveyor – 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 ID 1] The cooling tunnel must maintain the specified cooling temperature for suppositories. [H/M/L] [DQ Test Ref 1] [IQ…

Solvent Storage Tank (SS / GL) – 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 the solvent storage tank maintains appropriate level of solvents. M DQ-001 IQ-001 OQ-001 PQ-001 Level Calibration Log Pass/Fail…

Patch Coating Machine (Knife-over-roll / Slot Die) – 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 ID 1] The machine must accurately coat a drug adhesive layer onto the backing film. [H/M/L] [DQ Test Ref…

Filter Integrity Tester – 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 ID 1] Verify filter integrity using bubble point diffusion method. [H/M/L] [DQ Test Ref 1] [IQ Test Ref 1]…

Filter Housing (Sterile Grade) – 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 Filter housing must maintain pressure hold seal integrity during operation. H DQ-001 IQ-001 OQ-001 PQ-001 Pressure test report Pass…

Inline Static Mixer (if used) – 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_ID_1] The Inline Static Mixer shall achieve a defined mixing efficiency during formation. [H/M/L] [DQ_Test_Ref_1] [IQ_Test_Ref_1] [OQ_Test_Ref_1] [PQ_Test_Ref_1] [Evidence_Record_1] [Result_1]…