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:
Sterile Filtration Skid – PQ Protocol
Document Control: Document ID: PQ-SKID-001 Version: 1.0 Effective Date: YYYY-MM-DD Reviewed By: [Name] Approved By: [Name] Performance Qualification Protocol for Sterile Filtration Skid Objective: To validate the performance of the Sterile Filtration Skid used for filtering sterile bulk solutions in…
Dust Extraction Unit (LEV for dispensing) – 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] Ensure adequate airflow capture velocity for operator protection. [H/M/L] [DQ Test Ref 1] [IQ Test Ref 1]…
Filter Housing (Sterile Grade) – Deviation Impact Assessment
Deviation Impact Assessment Equipment Information Equipment: Filter Housing (Sterile Grade) Area: Production Criticality: Critical Product Impact: Direct CSV Required: No Deviation Details Description of Deviation: [Insert detailed description of the deviation here] Date of Deviation: [Insert date] Reported By: [Insert…