Treximo was engaged to support the initial retrospective review and risk evaluation of current and previously manufactured products under the site-driven review methodology. Treximo subject matter experts—experienced in Analytical Chemistry for aseptic and terminally sterilized drug product—provided batch-by-batch review of all products within the three-month commitment made to the FDA. Rationale was provided for each lot’s acceptance, further testing requirements, and/or lot rejection/recall.
At the initiation of the project, two firms were engaged: one to establish review methodology and project management, and Treximo for data review. Four weeks into the project, the client asked Treximo to replace the project methodology and management, citing SME understanding of the issues, professionalism, and rate appropriateness as rationale for full project ownership. Treximo deployed a project manager with experience working through multiple similar data integrity projects in India, China, and Eastern Europe to report to the Treximo PMO and client site leadership. Treximo also provided a chemistry SME and microbiology SME to support the managerial, technological, and educational improvements necessary in both departments. The team established the methodology for continued data review and a timeline for remediation quality improvements.
Interim Risk Mitigation and Continued Manufacture
Methodology provided by the Treximo team established risk-based guidelines for previous product release rationale and parameters for continued manufacture at the site. Due to drug shortages created by the review, continued product release became a high priority to the project. Treximo subject matter experts flexed to add support to the batch record review team, allowing new product release while supporting the three-month review timeline given to the agency.