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Data Integrity

The Challenge 

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 via 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.

The Solution 

Data Review

Planet Pharma provided talented resources that:

  • Completed batch-by-batch review of current and previously manufactured products within the three-month commitment made to the FDA.
  • Provided rationale for each lot’s acceptance, further testing requirements, and/or lot rejection/recall.

Project Management

We also deployed:

  • A project manager with experience working through multiple similar data integrity projects in India, China, and
    Eastern Europe.
  • Both a chemistry and microbiology SME to support the managerial, technological, and educational improvements necessary in each department.

The Results 

Planet Pharma provided the resources necessary for the client’s team to deliver the data review within the timeline provided, resulting in zero product recalls.

  • The talent we placed 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.