In light of the FDA’s Drug Supply Chain Security Act, many pharma manufacturers still find themselves grappling with the intricacies of compliance.
Although the U.S. Food and Drug Administration ’s Drug Supply Chain Security Act recently granted a reprieve for one year before sanctioning pharmaceutical companies, the November 27, 2023, deadline nevertheless remains.
The reprieve does not mean that companies can wait an extra year before implementing the right technologies and workflows to comply. The nuance is that the FDA will wait until November 24 before enforcing the Act. Distributors, third-party logistics and dispensers are also struggling with achieving 100% interoperability and accurate, reliable unit-level data between their trading partners’ systems and procedures. Not all partners are in lockstep with one another in terms of technology choices, deployment timelines,across the industry, demanding that the FDA evaluate the shortages and disruptions that are likely to occur due to DSCSA noncompliance and the lack of readiness by September 15, 2023.
Pharma manufacturers are increasingly bogged down by a stark labor shortage, but it’s still important to ensure the production and delivery processes are not siloed. One way to accomplish this is to consider the utilization of collaborative robots, or “cobots.” This innovation used along the production line is helping improve the industry from research to quality control.
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