High Shear Granulator (HSG) – Qualification Certificate Template

Qualification Certificate

Equipment: High Shear Granulator (HSG)

Subcategory: Solid Dosage Form (OSD)

Area: Production/Granulation

Qualification Type Status
Design Qualification (DQ) Yes
Installation Qualification (IQ) Yes
Operational Qualification (OQ) Yes
Performance Qualification (PQ) Yes

Equipment Identifiers: [Insert Equipment ID]

Protocol References: [Insert Protocol Ref]

Execution Dates: [Insert Execution Dates]

Calibration Status: [Insert Calibration Status]

Deviations Summary: [Insert Deviations Summary]

Overall Qualification Statement:

The High Shear Granulator has been successfully qualified for use in the production of solid dosage forms, meeting all necessary regulatory and operational requirements.

Approvals:

[Insert Approvals]

Next Due Date for Requalification:

[Insert Next Due Date] (Requalification Frequency: 24 Months)

See also  High Shear Granulator (HSG) – PQ Protocol