Since the DSCSA (Drug Supply Chain Security Act) was introduced and approved by Congress and the Senate there has been a real concerted effort to reach total compliance aided by the International Standards champion GS1 who has worked to insure US and Global compliance.
As the current date set for complete compliance and readiness has been set for November 27th, 2023 what a great time it is to contemplate moving to the next level of quality, safety and compliance by merging DSCSA and Cold Chain regulations temperature monitoring for those high value vaccines, pharma’ drugs and biologics.
Most drug manufacturers that need to be compliant with the DSCSA requirements in many cases have systems established already for temperature monitoring and management of their cold chain products, as well as established applications for checking at a minimum correct temperature and condition when a shipment leaves the warehouse until it arrives at its destination. In addition to this many of these companies have now embraced real time tracking and temperature monitoring, so if an excursion occurs it may well be possible to take corrective action to prevent a total loss of the shipment. The latter method of tracking in most cases comes with a cloud service so that logistics staffs know where the products are and what is happening with them during transit.
So now there are potentially two data bases that contain valuable data related to events that could directly affect the efficacy, safety, and compliance to regulations of the high valued drug related products as they go down the supply chain. However, currently each of these sets of data are unique and separate, thus creating a possible point where compliance data could be overlooked if only one data chain is in focus.
Although most companies are rapidly approaching compliance with DSCSA laws, or are already compliant, for many years prior to this they have been tracking and monitoring their cold chain products for temperature compliance, so this activity is not new. However, now might be a good time to investigate further the opportunity to have a single source point where both of these data streams come together. This will aid to ensure Total Compliance for both Serialization and Cold Chain data in an effort to guarantee that what is delivered to the patient is not only a non-counterfeit product, but where required it has also been monitored for temperature limits to insure efficacy and stability levels for the patient’s total safety and benefit.