Precision medicine requires end-to-end traceability: everything from chain of custody, to chain of condition, to chain of identity. But the fragility of regenerative medicine therapies – and the need to more effectively manage risk– means that a fourth chain will soon be a regulatory requirement: the Chain of Compliance™.
Industry experts believe that enhanced traceability within the temperature-controlled distribution will also be subjected to additional regulatory requirements due to the fragile aspect of the drug product and the disproportionate risk of improper cold chain management on the viability of the therapies.
CMC’s guidance in the FDA CFRs that dictate pharmaceutical manufacturing standards, describe a comprehensive quality systems (QS) model, highlighting the model's consistency with regulatory requirements for manufacturing human and veterinary drugs, including biological drug products. Records shall be made, concurrently with the performance, of each step in the manufacture and distribution of products, in such a manner that at any time successive steps in the manufacture and distribution of any lot may be traced by an inspector. Traceability must be a part of any long-term regenerative medicine supply chain management solution.
Traceability can be accomplished using Chain of Compliance™ processes which provide visibility and storage of critical data. Chain of Compliance™ provides full traceability of the equipment and processes used in managing the environmental control of the commodity. This includes equipment performance and requalification history, commodity history, courier handling and performance history, calibration history, and correlation competencies that can link in field events to equipment performance.
Robust data management is the key to mitigating risk and better understanding variability of an un-controlled system. The ability to collect, interpret, and leverage all of this data provides a more intelligent supply chain. Rather than trying to determine what has gone wrong after multiple failures, it becomes possible to take a proactive approach. Perhaps most importantly, robust near real-time data can alert you to problems before they become costly failures. Having the ability to assess risk and intervene when unexpected problems arise in transit has the power to save time, money, and even lives.
Cryoport is the only logistics provider in the life science industry that can provide compliance traceability within temperature-controlled distribution. Partner with Cryoport for your temperature-controlled logistics to ensure Chain of Compliance™ standards are part of your supply chain.