Challenge and approach
The old plant sits on a tight footprint, and the original production area already relied on work-arounds to meet GMP. New products were coming in by technology transfer, under updated rules, and the site had to know whether it could take them.
PE ZD reviewed it as consultant: feasibility and qualification of the cleanroom, HVAC, compressed air, vacuum, dust extraction, wastewater, plant steam, and electrical systems, judged on GMP design, operability, maintainability, cross-contamination risk, and how far the plant could be upgraded. The site is in Nantou. The products are small-molecule oral tablets and capsules. The targets are US FDA, EU EMA, and PIC/S GMP. Concept design and construction were not part of this job.
Scope
- HVAC
- Cleanroom
