About this Project
OBJECTIVE
This project aimed to provide engineering support for a new filing line.
SERVICES
PSC Biotech team supported the client by initially reviewing and providing advice on the design documents, i.e., functional specifications (FS), hardware design specifications (HDS), automation concepts, software design specifications (SDS), and computer specifications (CS). Our experts mapped the critical quality attributes (CQA) against the process parameters identified by the critical process parameters (CPPs), and generated system impact assessment (SIA) and critical component assessment (CCA). We also participated in design review meetings with the equipment suppliers and provided our expert advice on the design elements. Our team drafted the quality events such as change control for new and legacy equipment removal and installation, demolition, and remodeling of good manufacturing practices (GMP) and non-GMP rooms.
PROJECT SUCCESS
The project was completed, and the client was satisfied with the goals achieved.
