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Spheronizer / Marumerizer – 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 Verify the spheronizer operates within specified plate speed. M DQ-001 IQ-001 OQ-001 PQ-001 Calibration Certificate Pass URS-002 Confirm the…
De-lumper / Lump Breaker – OQ Protocol
Operational Qualification Protocol for De-lumper / Lump Breaker Document Number: OQ-001 Version: 1.0 Effective Date: [Insert Date] Review Date: [Insert Date] Prepared by: [Name] Approved by: [Name] Objective: To establish the operational qualification of the De-lumper / Lump Breaker to…
Sterile Holding Tank – DQ Protocol
Design Qualification Protocol for Sterile Holding Tank in Prefilled Syringes & Cartridges Document Number: DQ-001 Version: 1.0 Effective Date: 2023-10-01 Review Date: 2024-10-01 Objective The objective of this Design Qualification (DQ) protocol is to verify that the Sterile Holding Tank…