Colloid Mill (if used) – Qualification Certificate Template

Qualification Certificate

Equipment: Colloid Mill

Subcategory: Nasal & Otic Products (Sterile / Non-Sterile)

Area: Production

Equipment Identifier [Equipment Identifier]
Protocol Reference [Protocol Reference]
Execution Dates [Execution Dates]
Calibration Status [Calibration Status]
Deviations Summary [Deviations Summary Line]
Overall Qualification Statement The Colloid Mill has been successfully qualified for use in the production of Nasal & Otic Products, meeting all required specifications and standards.
Approvals [Approvals]
Next Due Date [Next Due Date]

Qualification Flags

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

Requalification Frequency

Requalification is required every 24 months.

See also  Solution Preparation Tank – Equipment Validation SOP