Qualification Execution Checklist
Equipment: Isolator / RABS (NDDS Filling)
Subcategory: NDDS – Liposomes & Lipid Nanoparticles (LNP)
Area: Production
DQ/IQ/OQ/PQ Flags: Yes/Yes/Yes/Yes
CSV Required: Yes
Also Check:
Solution Preparation Tank – 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] The Solution Preparation Tank must effectively dissolve ingredients and prepare formulation at specified conditions. [H/M/L] [DQ Test Ref]…
Prefilled Syringe Washing 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 washing machine must effectively remove particulates from syringes. [H/M/L] [DQ Test Ref 1] [IQ Test Ref…
Terminal Sterilization Autoclave (LVP) – DQ Protocol
Design Qualification Protocol for Terminal Sterilization Autoclave in IV Infusions Document ID: DQ-001 Version: 1.0 Effective Date: [Insert Date] Review Date: [Insert Date] Prepared by: [Insert Name] Approved by: [Insert Name] Objective The objective of this Design Qualification (DQ) protocol…