Isolator / RABS (NDDS Filling) – Qualification Certificate Template

Qualification Certificate

Equipment: Isolator / RABS (NDDS Filling)

Subcategory: NDDS – Liposomes & Lipid Nanoparticles (LNP)

Area: Production

Equipment Identifier [Equipment Identifier]
Protocol Reference [Protocol Reference]
Execution Date [Execution Date]
Calibration Status [Calibration Status]
Deviations Summary [Deviations Summary Line]
Overall Qualification Statement [Overall Qualification Statement]
Approvals [Approvals]
Next Due Date [Next Due Date]

Qualification Flags

  • Design Qualification (DQ): Yes
  • Installation Qualification (IQ): Yes
  • Operational Qualification (OQ): Yes
  • Performance Qualification (PQ): Yes

Requalification Frequency

12 Months

See also  Inline Heater / Heat Exchanger – Deviation Impact Assessment