Case Packer – Qualification Certificate Template

Qualification Certificate

Equipment Information

Equipment: Case Packer

Subcategory: IV Infusions (LVP/SVP – Bags/Bottles)

Area: Packaging/Secondary

Qualification Flags

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

Qualification Details

Equipment Identifier: [Equipment Identifier]

Protocol References: [Protocol References]

Execution Dates: [Execution Dates]

Calibration Status: [Calibration Status]

Deviations Summary

[Deviations Summary]

Overall Qualification Statement

The Case Packer has been qualified in accordance with the established protocols and is deemed suitable for use in the specified application.

Approvals

Approved By: [Approver Name]

Date of Approval: [Approval Date]

Next Due Date

Next Requalification Due: [Next Due Date]

See also  Lyophilizer (if lyophilized syringe/cartridge) – Deviation Impact Assessment