Qualification Certificate

Equipment Information

Equipment Name: Leak Test Machine (CCIT)

Subcategory: Prefilled Syringes & Cartridges

Area: Production/QC

Equipment Identifier: [Equipment Identifier]

Qualification Flags

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

Qualification Details

Protocol References: [Protocol References]

Execution Dates: [Execution Dates]

Calibration Status: [Calibration Status]

Deviations Summary: [Deviations Summary]

Overall Qualification Statement

The Leak Test Machine (CCIT) has been successfully qualified for use in the production of prefilled syringes and cartridges in accordance with the established protocols.

Approvals

Approved By: [Approver Name]

Date of Approval: [Approval Date]

Next Due Date

Next Requalification Due: [Next Due Date] (12 months from the last qualification)