Point person for the FDA inspection of a fine chemical manufacturing site


Prepare and handle the FDA inspection of a fine chemicals manufacturing site, where one of the site legacy products had been the object of a ANDA submission in the US


  • Complete overhaul of the manufacturing areas affected by the inspection (warehouse, production, QC, maintenance and engineering services)
  • Gap analysis and extensive mitigation program regarding the pharmaceutical quality system
  • Retrospective evaluation of the historical data supporting process consistency and robustness; writing of a validation master plan, conducting a process parameters criticality assessment and prospective PPQ protocols
  • Serve as the principal point of contact during the inspection
  • Successful outcome of the inspection: all F483 observations addressed in full and CAPA plan approved in the EIR