Challenge and approach
The product was already on the market, a topical liquid, and the lab still had to be rebuilt to PIC/S GMP.
The site is in Hsinchu County. PE ZD’s turnkey scope covered concept design, URS, risk assessment, design review, consulting and review of commissioning and qualification, construction, and test qualification. The facility stage includes detail design, construction, validation, and qualification.
Scope
- HVAC
- Cleanroom