Ben Venue

Background

Ben Venue was one of the largest generic injectable pharmaceutical companies in the United States, offering a broad range of multisource injectables across multiple therapeutic classes.They began an assessment of their regulatory compliance with FDA guidelines across all aspects of their organization.  Controlled-environment logistics was included in their internal assessment.

Objectives

  • Create a process map of the current logistics network.
  • Assess risk to patient safety, product quality, and regulatory compliance.
  • Recommend risk mitigation strategies for identified high risks.

Results

  • After identification of the risks in their cold chain,  eleven (11) major gaps in GDP compliance were closed.
  • Qualified thermal packaging solutions to current Good Distribution Practices (GDP) and industry benchmarks.
  • Ensured thermal packaging qualification and distribution operations completed audits with no findings.

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