Qualification Certificate

Equipment Information

Equipment: Aseptic Filling Machine (Vials/PFS/Cartridges)

Subcategory: NDDS – Liposomes & Lipid Nanoparticles (LNP)

Area: Production

Qualification Flags

DQ: Yes

IQ: Yes

OQ: Yes

PQ: Yes

Qualification Details

Equipment Identifiers: [Insert Equipment Identifiers]

Protocol References: [Insert Protocol References]

Execution Dates: [Insert Execution Dates]

Calibration Status: [Insert Calibration Status]

Deviations Summary: [Insert Deviations Summary Line]

Overall Qualification Statement

The Aseptic Filling Machine has been successfully qualified in accordance with the established protocols and regulatory requirements.

Approvals

Approved By: [Insert Approvals]

Next Due Date

Next Due Date: [Insert Next Due Date] (Requalification frequency: 12M)