Project Description
We worked with the manufacturer and their CMO to ensure mutli-site readiness for an essential PAI inspection. This PAI is for the approval of a generic product. We conducted onsite Mock inspections at both the manufacturing and CMO sites. Assisted with quality investigations of the manufacturing process, water system and computer system. Reviewed data that was part of the submission. Assisted with quality system upgrades that were required at the CMO site. Assisted client with documenting the transfer of products.