The Challenge

An FDA mock inspection performed at a CDMO site — at the client’s request — surfaced gaps that would have blocked FDA approval for inhalation product manufacturing. CDMO management responded with a strategic decision: build a new sterile production suite from the ground up, engineered specifically to withstand FDA Pre-approval Inspection (PAI). The project required everything from conceptual layout to equipment specifications to final qualification, with no margin for design rework once construction was underway.

The Approach

Arnan led the engineering thread end-to-end:

• Initial FDA mock inspection covering facility, equipment, systems, and procedures
• Recommendations for remediation and capability-building activities
• Conceptual layout for the new suite — room grading, pressure differentials, personnel and material flows
• URSs prepared for the filling machine and the autoclave
• Review and approval of autoclave qualification documentation
• Final inspection of the constructed suite
• Final FDA mock inspection prior to PAI submission

Each phase fed the next: the mock inspection findings shaped the conceptual design, the conceptual design shaped the equipment URSs, and the URSs anchored the qualification scope — a single coherent line of engineering reasoning from gap analysis to PAI readiness.

The Outcome

• Sterile suite constructed in line with the conceptual design
• Aseptic Processing Simulation (Media Fill) passed
• Suite qualified, operational, and ready for FDA Pre-approval Inspection
• Client positioned to submit inhalation products to the FDA
• Production conditions and capabilities improved beyond initial expectations