traceability matrix – Page 20

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]…

Colloid Mill (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-001 The Colloid Mill must effectively reduce particle size to specified limits. H DQ-001 IQ-001 OQ-001 PQ-001 Validation Report Pass…

Bottle Washing / Rinsing 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 bottles are thoroughly rinsed before filling. [H/M/L] [DQ Test Ref 1] [IQ Test Ref 1] [OQ…

Suppository Molding 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 the melted base into the molds accurately. [H/M/L] [DQ Test Ref 1] [IQ…

Distillation Unit / Distillation Column – 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 distillation unit operates within specified temperature ranges. H DQ-001 IQ-001 OQ-001 PQ-001 Temperature logs Pass/Fail URS-002 Verify…

Inline Sterile Filtration Skid – 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 Sterile Filtration Skid must ensure the integrity of the filtration process. [H/M/L] [DQ Test Ref…

Sterile Filtration Skid – 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 filtration skid maintains sterile conditions during operation. H DQ-001 IQ-001 OQ-001 PQ-001 Validation Report Pass/Fail URS-002 Verify…

Ophthalmic Sterile Filtration Skid (0.22 µm) – 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 Confirm the skid meets design specifications for sterile filtration. M DQ-Ref-001 IQ-Ref-001 OQ-Ref-001 PQ-Ref-001 Design Specification Document URS-002 Verify…

Microfluidic Mixer (LNP/Liposome Formation) – 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 microfluidic mixer must ensure controlled nanoparticle formation. H DQ-001 IQ-001 OQ-001 PQ-001 Validation Report 001 URS-002 The mixer…

Bottle Blow Molding 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 bottle blow molding machine must maintain the specified temperature during the molding process. [H/M/L] [DQ Test…