Qualification Certificate

Equipment Information

Equipment Name: Blister Packing Machine (Thermoform)

Subcategory: Solid Dosage Form (OSD)

Area: Packaging/Primary

Qualification Flags

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

Protocol References

DQ Protocol Ref: [Insert DQ Protocol Reference]

IQ Protocol Ref: [Insert IQ Protocol Reference]

OQ Protocol Ref: [Insert OQ Protocol Reference]

PQ Protocol Ref: [Insert PQ Protocol Reference]

Execution Dates

DQ Execution Date: [Insert DQ Execution Date]

IQ Execution Date: [Insert IQ Execution Date]

OQ Execution Date: [Insert OQ Execution Date]

PQ Execution Date: [Insert PQ Execution Date]

Calibration Status

Calibration Status: [Insert Calibration Status]

Deviations Summary

Deviations Summary: [Insert Deviations Summary]

Overall Qualification Statement

The Blister Packing Machine (Thermoform) has been successfully qualified in accordance with the protocols referenced above, and is deemed suitable for use in the Packaging/Primary area for Solid Dosage Forms.

Approvals

Prepared By: [Insert Prepared By]

Approved By: [Insert Approved By]

Next Due Date

Next Due Date: [Insert Next Due Date – 12M]