Sentry BioPharma Services announced the successful opening of a qualified shipping lane for pharmaceutical drug product between its facility in Indianapolis, Indiana and San Juan, Puerto Rico.
On August 17th, 2016 a dry ice shipment of drug product was delivered to San Juan, PR, 00926 via FedEx International Priority Service. The -80º Celsius product arrived next day in San Juan within the qualified temperature range.
Background. As pharmaceutical cold chain management has become a more critical component in the global biopharmaceutical supply chain, regulatory agencies and industry associations have been launched solely to develop standards for compliance in this market. Achieving regulatory compliance was a much simpler task in traditional supply chain models of the past. Now, due to an increasingly complex set of social, scientific and political pressures, industry mandates and international regulations have become significantly more stringent. Each country has its own body of rules and guidelines governing the shipment and handling of pharmaceutical and biological products. A qualified pharmaceutical cold chain management and 3PL partner must demonstrate compliance with international guidelines.
In addition to mandates prescribed by external regulatory agencies, the industry has begun to develop its own body of industry-accepted standards for biopharmaceutical distribution and handling. Several prominent groups have been formed throughout the world to discuss regional challenges and issues; collaborate on problem-solving; examine emerging trends; and define industry best practices. A pharmaceutical cold chain management partner should be familiar with the standards being developed by leading international pharmaceutical discussion groups.
Custom Pharmaceutical Product Management, Distribution and Patient Support
Sentry provides scalable clinical trial and commercial pharmaceutical drug distribution globally. As with all programs, Sentry maintains regulatory compliance and transparency in fulfilling orders placed by clinics, hospitals, pharmaceutical distributors and other licensed recipients.
|Clinical and Commercial Drug Distribution Support
Sentry, as a cold chain logistics partner can provide immediate access to its state-of-the-art GMP storage facility that has been designed to meet the unique requirements of temperature-sensitive drug products. It offers: validated, temperature controlled storage and temperature-monitoring equipment; redundant power, cooling and environmental monitoring systems; redundant data storage capabilities; and sophisticated data security systems.
For more information about how Sentry’s cold chain management programs can ensure biological product integrity in every phase of the pharmaceutical supply chain, contact Sentry via email or by phone at 1-866-757-7400.