Location: Bedford, OH
Project Cost: Confidential
This client is a multinational oncology contract manufacturer. Their production was ceased at the instruction of US-FDA to reflect further changes to the Validation Approach or to the scope of the equipment, facility, or utilities.
PharmEng provided various services to restart production for four manufacturing facilities at the client’s site, which supported multiple lines. The services that we provided made certain that the client’s processes and equipment complied with FDA requirements and include: