De-lumper / Lump Breaker – Qualification Certificate Template

Qualification Certificate

Equipment Information

Equipment: De-lumper / Lump Breaker

Subcategory: Solid Dosage Form (OSD)

Area: Production/Sieving

Qualification Flags

Design Qualification (DQ): Yes

Installation Qualification (IQ): Yes

Operational Qualification (OQ): Yes

Performance Qualification (PQ): Yes

Qualification Details

Equipment Identifier: [Equipment Identifier]

Protocol References: [Protocol References]

Execution Dates: [Execution Dates]

Calibration Status: [Calibration Status]

Deviations Summary: [Deviations Summary]

Overall Qualification Statement

The De-lumper / Lump Breaker has been qualified in accordance with the applicable protocols and is deemed suitable for use in the production of solid dosage forms.

Approvals

Approved By: [Approver Name]

Approval Date: [Approval Date]

Next Due Date

Next Due Date for Requalification: [Next Due Date] (Requalification frequency: 24 Months)

See also  Weighing Balance (Platform/Floor) – OQ Protocol