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] The system should maintain an audit trail for fill weight reject logic. [H/M/L] [DQ_Test_Ref_2] [IQ_Test_Ref_2] [OQ_Test_Ref_2] [PQ_Test_Ref_2] [Evidence_Record_2] [Result_2]
[URS_ID_3] The equipment must comply with regulatory standards for inhalation devices. [H/M/L] [DQ_Test_Ref_3] [IQ_Test_Ref_3] [OQ_Test_Ref_3] [PQ_Test_Ref_3] [Evidence_Record_3] [Result_3]
[URS_ID_4] Fill weight must be validated under specified environmental conditions. [H/M/L] [DQ_Test_Ref_4] [IQ_Test_Ref_4] [OQ_Test_Ref_4] [PQ_Test_Ref_4] [Evidence_Record_4] [Result_4]
See also  Roller Compactor – IQ Protocol

Also Check:

IV Bag Form-Fill-Seal (FFS) Machine – Deviation Impact Assessment

Deviation Impact Assessment Equipment Details Equipment: IV Bag Form-Fill-Seal (FFS) Machine Area: Production Criticality: Critical Product Impact: Direct CSV Required: Yes Deviation Details Description of Deviation: [Insert detailed description of the deviation] Date of Deviation: [Insert date] Classification Deviation Classification:…

Ophthalmic Holding Tank (Sterile/Pressurized) – DQ Protocol

Document ID: DQ-OPHT-001 Version: 1.0 Effective Date: [Insert Date] Review Date: [Insert Date] Design Qualification Protocol for Ophthalmic Holding Tank This document outlines the Design Qualification (DQ) protocol for the Ophthalmic Holding Tank utilized in the production of sterile eye…