Engineering and CQV Services for Pharmaceutical Client

PSC Biotech® provided Engineering, Commissioning, Qualification and Validation services for the client reactor at pilot facility.

Area: Texas
Project Type: Engineering, Commissioning, Qualification, Validation

About this Project

OBJECTIVE

The goal of this project was to provide Engineering, Commissioning, Qualification and Validation Services for upgrading and qualification for 50 L Reactor at the clients Pilot Manufacturing site.

SERVICES

PSC Biotech supported with the qualification, commissioning, validation, and other Engineering for 50L Reactor. As part of this project, PSC supported the Validation Protocol development, developing Qualification Plan, developing initial qualification documentation, execution, and final reports for different equipment and processes. PSC also supported in developing or updating of relevant SOPs for this project. Apart from Quality Assurance and technical writing support, PSC helped in the smooth planning and execution of the project through its project management expertise.

Project Success

The client was very happy with the smooth execution of all the deliverables as well as PSC’s support with documentation as well as project management aspects within the specified timeframe.