Sterile Filtration Skid (if feasible) – Qualification Certificate Template

Qualification Certificate

Equipment Details

Equipment Name: Sterile Filtration Skid

Subcategory: NDDS – Liposomes & Lipid Nanoparticles (LNP)

Area: Production

Equipment Identifier: [Insert Equipment Identifier]

Qualification Flags

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

Qualification Protocols

Protocol References: [Insert Protocol References]

Execution Details

Execution Dates: [Insert Execution Dates]

Calibration Status: [Insert Calibration Status]

Deviations Summary

[Insert Deviations Summary]

Overall Qualification Statement

The Sterile Filtration Skid has been qualified in accordance with the established protocols and is deemed suitable for use in the production of NDDS – Liposomes & Lipid Nanoparticles (LNP).

Approvals

Approved By: [Insert Approver Name]

Date of Approval: [Insert Approval Date]

Next Due Date

Next Requalification Due Date: [Insert Next Due Date]

See also  Glass Lined Reactor (GLR) – DQ Protocol