The FDA FSMA legislation includes a variety of new mandates to help prevent product contamination, improve food inspection processes, shorten recall response periods, raise food product import standards and facilitate cooperation between regulatory agencies. Once all of these mandates have been implemented across the US and with countries involved in trade the handling of consumable inventory will be more closely monitored and audit trail data accessible in real-time.
The FDA DSCSA legislation serves a similar purpose as that of the FSMA. The Drug Supply Chain Security Act will directly affect supply chain businesses and how they produce, trace, verify and handle regulated pharmaceutical-grade products. The new provisions added under DSCSA include more stringent standards for product identification, product tracing, product verification, detection & response and FDA notification. This legislation, like FSMA will require all supply chain businesses to provide detailed audit trail data relating to each inventory item handled as it enters, moves throughout and exits their facility.
In an effort to assist supply chain businesses remain complaint with these regulations, the GS1 agency has developed the GS1 traceability Standard. This standard defines the rules and requirements that should be used when designing and implementing a compliant traceability solution. Supply chain software and hardware vendors are utilizing these standards when designing solutions used for inventory track and trace. This takes the guess work out for the manufacturers, 3PLs, distributors, wholesalers, repackagers and retailers handling regulated inventory. The top tools designed for the automation of inventory track and trace include warehouse management software, RFID, automated data collection devices and temperature recorders. A combination of these solutions designed to meet FDA standards can help to improve consumer safety and supply chain compliance.