Qualification Certificate

Equipment: Nanoparticle Reactor (Batch)

Subcategory: NDDS – Polymeric Nanoparticles (PLGA etc.)

Area: R&D/Production

Equipment Identifiers: [Equipment ID]

Protocol References: [Protocol Ref]

Execution Dates: [Execution Dates]

Calibration Status: [Calibration Status]

Qualification Flags

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

Deviations Summary: [Deviations Summary]

Overall Qualification Statement

The Nanoparticle Reactor has been successfully qualified for use in the R&D/Production of polymeric nanoparticles (PLGA etc.) in accordance with the established protocols and standards.

Approvals

Approved By: [Approver’s Name]

Date of Approval: [Approval Date]

Next Due Date

Requalification Frequency: 12 Months

Next Due Date: [Next Due Date]