Extruder (Twin Screw) – Qualification Certificate Template

Qualification Certificate

Equipment Details

Equipment: Extruder (Twin Screw)

Subcategory: Solid Dosage Form (OSD)

Area: Production/Pellets

Qualification Flags

DQ: Yes

IQ: Yes

OQ: Yes

PQ: Yes

Qualification Details

Equipment Identifier: [Equipment Identifier]

Protocol Reference: [Protocol Reference]

Execution Date: [Execution Date]

Calibration Status: [Calibration Status]

Deviations Summary

[Deviations Summary Line]

Overall Qualification Statement

The Extruder (Twin Screw) has been successfully qualified in accordance with the established protocols and is deemed suitable for use in the production of Solid Dosage Forms (OSD).

Approvals

Prepared By: [Prepared By]

Reviewed By: [Reviewed By]

Approved By: [Approved By]

Next Due Date

Requalification Due: [Next Due Date]

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