traceability matrix – Page 18

Ultrasonicator (Probe/Bath) – 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 Ultrasonicator must achieve the specified power amplitude for effective size reduction. [H/M/L] [DQ_Test_Ref_1] [IQ_Test_Ref_1] [OQ_Test_Ref_1] [PQ_Test_Ref_1] [Evidence_Record_1] [Result_1]…

Solution Preparation Tank (Salt/Sugar Dissolution) – 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 Temperature should be maintained within specified limits during dissolution. H DQ-001 IQ-001 OQ-001 PQ-001 Temperature log URS-002 Agitation time…

Suppository Cutting Machine – 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 cutting precision alignment for optimal performance. H DQ-001 IQ-001 OQ-001 PQ-001 Record-001 Pass URS-002 Verify calibration of cutting…

Lamination Machine – 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 The lamination machine must ensure proper pressure application for effective lamination. H DQ-001 IQ-001 OQ-001 PQ-001 Pressure Calibration Report…

Sterile Holding Tank (Pressurized) – 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 Verify pressure hold vent integrity H DQ-001 IQ-001 OQ-001 PQ-001 Pressure Test Report Pass/Fail URS-002 Confirm PLC logs functionality…

Prefilled Syringe Filling Machine – 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 fill sterile drug into syringes with a specified volume. [H/M/L] [DQ Test Ref 1]…

Ophthalmic Filling Machine (Dropper Bottles) – 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 The equipment must accurately fill dropper bottles to the specified volume. H DQ-001 IQ-001 OQ-001 PQ-001 Filling Accuracy Report…

Extrusion System (Liposome Extruder) – 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 extrusion system maintains specified pressure during operation. H DQ-001 IQ-001 OQ-001 PQ-001 Pressure logs Pass/Fail URS-002 Verify…

LVP/SVP Compounding Vessel (Jacketed SS) – 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] [URS Statement 1] [H/M/L] [DQ Test Ref 1] [IQ Test Ref 1] [OQ Test Ref 1] [PQ…

Suppository Stripping Machine – 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] Ensure stripping alignment is accurate to prevent product damage. [H/M/L] [DQ Test Ref 1] [IQ Test Ref…