traceability matrix – Pharma Validation

Osmometer (for parenteral NDDS) – 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 osmometers shall provide accurate osmolality measurements within specified limits. [H/M/L] [DQ Test Ref 1] [IQ Test…

In-vitro Release Testing System (Dialysis/Flow-through/USP apparatus as applicable) – 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 must be maintained within specified limits during testing. M DQ-001 IQ-001 OQ-001 PQ-001 Temperature log Pass URS-002 Agitation…

Encapsulation Efficiency Measurement Setup (HPLC/UPLC + separation) – 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 accuracy of encapsulation efficiency measurements H DQ-001 IQ-001 OQ-001 PQ-001 Calibration certificate URS-002 Verify linearity of assay results…

TEM / SEM (as GMP-supporting analytics) – 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 resolution calibration is performed to verify imaging capabilities. H DQ-001 IQ-001 OQ-001 PQ-001 Calibration Certificate URS-002 Verify image…

Nano Tracking Analysis (NTA) 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 accurate measurement of particle concentration. H DQ-001 IQ-001 OQ-001 PQ-001 Calibration Certificate URS-002 Maintain data integrity through audit…

Laser Diffraction Particle Size Analyzer – 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 measure particle size distribution within specified limits. H DQ-001 IQ-001 OQ-001 PQ-001 Calibration Certificate Pass…

Zeta Potential Analyzer – 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-001] The Zeta Potential Analyzer must accurately measure surface charge. H [DQ-Test-Ref-001] [IQ-Test-Ref-001] [OQ-Test-Ref-001] [PQ-Test-Ref-001] [Evidence-Record-001] [Result-001] [URS-ID-002] The Zeta…

Dynamic Light Scattering (DLS) Analyzer – 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 DLS Analyzer must accurately measure particle size within specified limits. [H/M/L] [DQ Test Ref 1] [IQ…

Water System (PW/WFI) – Point of Use for LVP – 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…

Capsule/Blister Filler for 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] The equipment must ensure accurate fill weight uniformity for inhalation powder. [H/M/L] [DQ_Test_Ref_1] [IQ_Test_Ref_1] [OQ_Test_Ref_1] [PQ_Test_Ref_1] [Evidence_Record_1] [Result_1] [URS_ID_2]…