The Brief
A generics company was expanding from contract packaging into own-label oral solid dosage manufacturing — their first GMP production facility. They needed to convert an existing warehouse into a fully qualified OSD suite.
The Challenge
Converting a warehouse with no cleanroom infrastructure into a GMP-compliant manufacturing facility with ISO 14644-1 Class D cleanrooms, contained powder handling, and a fully validated MES. The client had a 4-person project team with limited capital project experience — they needed technical leadership, not just project administration.
Our Approach
We acted as Owner's Engineer, embedded in the client's team. We ran vendor selection for all major equipment (7 vendors across 4 countries), designed the cleanroom HVAC system, managed the GAMP 5 validation for the MES integration, and prepared the full inspection dossier for IGJ. The warehouse conversion was designed for phased expansion — the initial build covers 40% of the available floor area, with pre-installed utilities and HVAC capacity for future lines.
Results
IGJ inspection passed with zero findings — manufacturing license issued in 4 weeks
7 equipment vendors coordinated across 4 countries
Warehouse-to-GMP conversion completed in 11 months