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 the integrity of the filtration system under flow conditions. H DQ-Ref-002 IQ-Ref-002 OQ-Ref-002 PQ-Ref-002 Integrity Test Results
URS-003 Ensure the integration audit trail is functioning correctly. M DQ-Ref-003 IQ-Ref-003 OQ-Ref-003 PQ-Ref-003 Audit Trail Verification Report
URS-004 Assess the flow rate during operation to ensure compliance. L DQ-Ref-004 IQ-Ref-004 OQ-Ref-004 PQ-Ref-004 Flow Rate Test Results
See also  Air Shower – Qualification Execution Checklist

Also Check:

Vision System (Label/Code Verification) – Qualification Execution Checklist

Qualification Execution Checklist Equipment: Vision System (Label/Code Verification) Subcategory: Solid Dosage Form (OSD) Area: Packaging/Inspection DQ/IQ/OQ/PQ: Yes/Yes/Yes/Yes CSV Required: Yes Pre-start Training completed SOPs reviewed and approved User Requirements Specification (URS) approved Regulatory Approval (RA) obtained Calibration/PM Status Verification Calibration…

Drum Lifter – Qualification Certificate Template

Qualification Certificate Equipment Information Equipment Name: Drum Lifter Subcategory: Solid Dosage Form (OSD) Area: Production/Material Handling Qualification Flags DQ: Yes IQ: Yes OQ: Yes PQ: No Qualification Details Equipment Identifier: [Equipment Identifier] Protocol Reference: [Protocol Reference] Execution Date: [Execution Date]…

Cartoning Machine – DQ Protocol

Document Control Number: DQ-OSD-CM-001 Version: 1.0 Effective Date: 2023-10-01 Reviewed By: [Reviewer Name] Approval Date: [Approval Date] Design Qualification Protocol for Cartoning Machine in Solid Dosage Form Validation Objective: To establish a Design Qualification (DQ) protocol for the validation of…