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.
- 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.
- 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.