Qualification

Validation Support Services (FDA, HPB, EEC, ISPE)

  • Validation Master Plan (VMP)
  • Installation Qualification (IQ)
  • Operation Qualification (OQ))
  • Performance Qualification (PQ)
  • Process Validation (PV)
  • Cleaning validation
  • SOP Procedures development & review of facility, equipment installation, operation, maintenance, calibration, cleaning, shutdown, commissioning & start-up
  • Sampling & maintenance programs & schedule
  • Project closure
  • Customer project handover
  • Post-mortem

Pharma Bio Expert, your cGMP Regulation & Engineering Compliance Partner