traceability matrix – Page 14

Sterile Powder 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] The vessel must maintain specified agitation speed during operation. [H/M/L] [DQ Test Ref 1] [IQ Test Ref…

Prefilled Syringe Washing 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 washing machine must effectively remove particulates from syringes. [H/M/L] [DQ Test Ref 1] [IQ Test Ref…

Sachets & Stick Packs (Non-Sterile) – 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] [Risk_1] [DQ_Test_Ref_1] [IQ_Test_Ref_1] [OQ_Test_Ref_1] [PQ_Test_Ref_1] [Evidence_Record_1] [Result_1] [URS_ID_2] [URS_Statement_2] [Risk_2] [DQ_Test_Ref_2] [IQ_Test_Ref_2] [OQ_Test_Ref_2] [PQ_Test_Ref_2] [Evidence_Record_2] [Result_2] [URS_ID_3] [URS_Statement_3]…

Ophthalmic 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-001 The equipment shall maintain agitation within specified parameters. M DQ-001 IQ-001 OQ-001 PQ-001 Agitation Log URS-002 The equipment shall…

Lipid Melting / Lipid Preparation Vessel (Jacketed SS/Glass) – 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 the vessel can maintain specified temperature for lipid phase preparation. [H/M/L] [DQ Test Ref 1] [IQ…

Nasal/Otic 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-001 The vessel must maintain agitation during mixing. M DQ-001 IQ-001 OQ-001 PQ-001 Agitation Log [Result] URS-002 The vessel must…

IV Bag Form-Fill-Seal (FFS) 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 machine shall form IV bags at the specified forming temperature. H DQ-001 IQ-001 OQ-001 PQ-001 Forming Temp Record…

DPI – 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 Base Melting 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] The melting vessel must maintain a uniform temperature for effective melting of PEG. [H/M/L] [DQ Test Ref…

mAbs – 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 equipment operates within specified temperature range H DQ-001 IQ-001 OQ-001 PQ-001 Temperature logs Pass URS-002 Verify equipment can…