In-vitro Release Testing System (Dialysis/Flow-through/USP apparatus as applicable) – Qualification Certificate Template

Qualification Certificate

Equipment: In-vitro Release Testing System

Subcategory: NDDS – Critical NDDS Analytics (CQA/CPP)

Area: QC/R&D

Equipment Identifier [Equipment Identifier]
Protocol Reference [Protocol Reference]
Execution Dates [Execution Dates]
Calibration Status [Calibration Status]
Deviations Summary [Deviations Summary]
Overall Qualification Statement The In-vitro Release Testing System has been qualified in accordance with established protocols and meets all specified requirements.
Approvals [Approvals]
Next Due Date [Next Due Date]

Qualification Flags

  • DQ: Yes
  • IQ: Yes
  • OQ: Yes
  • PQ: Yes

Requalification Frequency

12 Months

See also  Patch Pouch Packaging Machine – Qualification Execution Checklist