Pharmaceutical products pose unique challenges over general commodities. And it is imperative that you partner with a specialized service provider to ensure safe and secure shipments. Pharmaceuticals, vaccines, biologics, medical equipment, and products in development will require time-critical and temperature-sensitive shipment methods to maintain quality and integrity.
Rules for Shipping Pharmaceuticals
The Code of Federal Regulations (CFR) Title 21 sets the standards for regulatory requirements on life science products for the FDA, DEA, and ONDCP. There are established guidelines that must be maintained throughout the shipping process to stay compliant with Current Good Distribution Practices (CGDP), which are part of a GxP approach.
Important Factors for Pharmaceutical Shipments
Pharma products must maintain strict temperature guidelines, which can vary. According to the individual product, the packaging details, and the shipment transit time. Shippers will be required to develop a comprehensive shipping program including temperature-validated packaging materials, temperature monitoring devices, and contingency plans in case of incidents during shipment. Time and temperature performance along with proper security planning will be essential.
Pharmaceutical Insurance Coverage
Underwriters at Falvey Insurance Group specialize in underwriting life science risks among other industry interests. They know the proper questions to ask and considerations to take in assessing packaging, shipping, and handling of life science products. We offer Marine Cargo and Stock Throughput coverages tailored to client product needs on a custom basis.
Knowledgeable Underwriters and a highly-experienced team of Loss Prevention staff will be able to discuss your individual shipment needs. Troubleshooting the end-to-end supply chain process, and making best-practice recommendations.
Issues to be discussed:
- Product packaging, shipping, and handling
- Product temperature requirements and methods of temperature control
- Carrier vetting, selection, and performance assessments
- Comprehensive security protocols
- Shipment tracking and monitoring
- Development of appropriate/customized terms of service
Protect Your Pharmaceutical Shipments with Falvey Insurance Group’s Comprehensive Marine Cargo
Falvey Insurance Group offers policies for brokers, businesses, contractors, and more to help protect their vulnerable pharmaceutical assets while in transport. If you would like to learn more about how your pharmaceutical shipments can be best protected, please visit our marine cargo and pharmaceutical coverage page to see what would work best for your needs. For more detailed information and how to best accommodate your unique situation, you can contact us directly to help answer your questions.
Please reach out to us today to discuss the details of your pharmaceutical shipping program.
