Qualification Certificate

Equipment Information

Equipment: Safety Device Assembly Machine

Subcategory: Prefilled Syringes & Cartridges

Area: Production

Qualification Flags

Design Qualification (DQ): Yes

Installation Qualification (IQ): Yes

Operational Qualification (OQ): Yes

Performance Qualification (PQ): Yes

Requalification Information

Requalification Frequency: 12 Months

Execution Details

Equipment Identifiers: [Equipment Identifier]

Protocol References: [Protocol Reference]

Execution Dates: [Execution Date]

Calibration Status: [Calibration Status]

Deviations Summary

Deviations Summary: [Deviations Summary Line]

Overall Qualification Statement

Overall Qualification Statement: The Safety Device Assembly Machine has been successfully qualified for use in the production of prefilled syringes and cartridges.

Approvals

Approved By: [Approver Name]

Date of Approval: [Approval Date]

Next Due Date

Next Due Date: [Next Due Date]