Lyophilizer (if lyophilized syringe/cartridge) – Qualification Certificate Template

Qualification Certificate

Equipment Information

Equipment: Lyophilizer

Subcategory: Prefilled Syringes & Cartridges

Area: Production

Qualification Flags

DQ: Yes

IQ: Yes

OQ: Yes

PQ: Yes

Requalification Details

Requalification Frequency: 12 Months

Next Due Date: [Next Due Date]

Execution Details

Protocol References: [Protocol References]

Execution Dates: [Execution Dates]

Calibration Status: [Calibration Status]

Deviations Summary

[Deviations Summary Line]

Overall Qualification Statement

This Lyophilizer has been successfully qualified for use in the production of prefilled syringes and cartridges, meeting all required specifications and standards.

Approvals

Approved By: [Approver Name]

Date of Approval: [Approval Date]

See also  Pin Mill – DQ Protocol