Qualification Certificate

Equipment Information

Equipment: Aseptic Filling (PFS/Vials) for LAI

Subcategory: NDDS – Long-Acting Injectables (Depot Suspensions)

Area: Production

Qualification Flags

• DQ: Yes
• IQ: Yes
• OQ: Yes
• PQ: Yes

Qualification Details

Equipment Identifier: [Insert Identifier]

Protocol Reference: [Insert Protocol Reference]

Execution Dates: [Insert Execution Dates]

Calibration Status: [Insert Calibration Status]

Deviations Summary: [Insert Deviations Summary]

Overall Qualification Statement

The Aseptic Filling (PFS/Vials) for LAI has been successfully qualified in accordance with established protocols and regulatory requirements.

Approvals

Approved By: [Insert Approver Name]

Approval Date: [Insert Approval Date]

Next Due Date

Requalification Frequency: 12 Months

Next Due Date: [Insert Next Due Date]