Context and challenges
This client is a major pharmaceutical company, with several vaccines production sites in Belgium.
After an FDA inspection, the company’s representatives committed to reduce to less than 5% the amount of late deviations on a global scale (i.e., greater than 30 days old). This backlog of deviations that had to be corrected affected one of its biological product filling facilities.
Addressing this deviation’s issue was an obligation to ensure compliance with regulation.
Also, the numerous deviations increased internal costs (of investigation, storage, and machine shutdowns) and prevented product release. Indeed, it decreased available stock of products, jeopardizing the supply chain, and thus potential revenues.
This client has appointed Assystem Care to define and set up an improvement plan to reduce the number of deviations in a timely manner to comply with regulatory requirements and implement continuous operational quality improvement measures.
CAPA measures implemented