Validation

V Model Approach for Equipment Qualification Test
  • The V model is mainly used to manage validation steps for production and supporting equipment such as vessels.
  • The V model uses protocols to connect the design qualification test (DQ) documents, the installation and
    operation qualification test (OQ) documents and the performance qualification test (PQ) documents.
Qualification Test on Vessels
While vessels directly affect products, some vessels play process supporting roles. Whether to perform the qualification test or
only commissioning is determined by the purpose of use. The risk assessment may be used to make such decision.
  • Typical vessels required of the qualification test are as follows :
  • Liquid drug dispensingVessel
  • Synthetic Vessel
  • Injection dispensingVessel
  • IBC/Blender
  • Bio and cultur Vessel
  • Purified water and distilled water storage tanks
Process Validation Flow(Process Validation)