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Case Study 2: Data Integrity

Overview

Our Client, an international manufacturer of parenteral drug solutions, found inconsistencies in their laboratory data suggestive of manipulation. In order to substantiate previous product releases, risk evaluation and mitigation through retrospective review was required for all products manufactured at the site. As assurance for future release, an additional data integrity plan was needed to ensure
current and future employees were trained and data collection systems were properly protected, per 21 CFR Part 11.

Key Challenges

  • 100% Retrospective Review of over 3000+ batch records
  • Incomplete understanding of initial risk to product
  • Aging testing and data retention technology
  • Dated & undermanaged educational programs
  • Restrictive site budget for quality improvement programs and consultant support
  • Lack of central PMO for remediation

Treximo Solution

Data Review

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.

Project Management

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.

Outcome

The Treximo team delivered the data review within the timeline provide to the agency, resulting in zero product recalls. The team continued to provide oversight for the microbiology and chemistry laboratories, re-establishing the site’s governing practices and providing lean laboratory metrics for personnel management standards. The site has received no regulatory action to date, a reflection of the robust risk and review criteria used for the protocol.

Case Studies

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Remediation

Data Integrity

Program Integration