Depyrogenation Tunnel (if glass bottles) – Qualification Certificate Template

Qualification Certificate

Equipment Information

Equipment: Depyrogenation Tunnel

Subcategory: IV Infusions (LVP/SVP – Bags/Bottles)

Area: Production

Qualification Status

DQ: Yes

IQ: Yes

OQ: Yes

PQ: Yes

Qualification Details

Equipment Identifier: [Equipment Identifier]

Protocol Reference: [Protocol Reference]

Execution Dates: [Execution Dates]

Calibration Status: [Calibration Status]

Deviations Summary: [Deviations Summary]

Overall Qualification Statement

The Depyrogenation Tunnel has been qualified in accordance with the established protocols and is deemed suitable for use in the production of IV infusions.

Approvals

Qualified By: [Qualified By]

Approved By: [Approved By]

Next Due Date

Next Due Date: [Next Due Date]

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