Turning Around a Stalled Extraction & API Facility Project
The Situation A capital-intensive project to build an EU-GMP extraction and API manufacturing facility was at risk of failure. Due to planning errors and vendor misalignment, the project faced massive delays, budget overruns, and a high probability of certification denial.
My Intervention I took over Project Leadership & Recovery, conducting an immediate gap analysis to identify critical flaws.
- Architectural Realignment: Corrected design errors in the cleanroom layout and HVAC systems to meet strict pharmaceutical API standards.
- Vendor Management: Renegotiated with technology suppliers to ensure equipment interoperability and validation readiness.
- Regulatory Course Correction: Implemented a compliant QMS structure to prepare the facility for a successful authority inspection.
The Outcome The project was brought back on track and successfully achieved EU-GMP certification for API manufacturing , transforming a potential sunk cost into a fully operational, revenue-generating asset.