Objective
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
Outcome
- 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