Case Study

Environmental Monitoring Performance Qualification (EMPQ) And Validation Support Services

Source: CAI
Field Service Automation

CAI, a global consulting firm, was hired by a growing pharmaceutical/biotech company in 2022 to qualify a new series of aseptic processing rooms. The project involved room qualifications, sampling methods, and air handling unit qualifications. CAI provided direct support by generating protocols, executing the project, and providing closeout support. The firm also provided additional quality control laboratory staff and offered continuous support throughout the project. This partnership allowed the client to increase its aseptic manufacturing space by nearly 50%. Over the past two years, CAI has expanded its services to include support for the client's validation teams, container closure integrity testing validations, stability study work, and several computer system validation and equipment qualification projects. CAI's agents have continued to support the client's operational efforts while maintaining quality standards.

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