Although the universal standard for pharmaceutical track-and-trace solutions has yet to emerge, the California Board of Pharmacy’s ePedigree requirements are currently driving action in efforts toward implementing serialization to provide supply chain integrity to the public. While several states are actively pursuing similar legislation, California’s pending requirements are the most demanding since they track product to the smallest saleable unit level. Enforcement of the ePedigree legislation, combined with the accelerated pace of regulatory involvement worldwide in serialization and track-and-trace means that it is now vital for the industry to accelerate its efforts to put compliance measures in place.
Read More →Serialization: Optimizing Planning and Implementation
Increased globalization in the supply chain for prescription drugs has also increased the distribution of counterfeit drugs. To combat this problem in the U.S., the FDA has outlined requirements to make every unit of saleable prescription drug products traceable. Meeting the requirements for these regulations requires a long-term strategy and preparation. Recro Gainesville, understanding the changing manufacturing landscape, began this process years in advance. Product serialization enables manufacturers and distributors to protect consumers from potentially harmful counterfeit and stolen drug products by improving supply chain tracking, visibility and management.
Read More →In the Global Life Sciences Market, What You Don’t Know CAN Hurt You
The global life sciences market is witnessing an unprecedented pace of change across pharmaceuticals, medical devices, and biologics. It’s the new normal as trends like big data, the Internet of Things, increasing supply chain complexity and the advance of biosimilars create new opportunities – and challenges – for life sciences companies. As regulators around the globe scramble to stay abreast of these trends, they are making important and often major updates to directives. Quite often these directives are not coordinated between markets, creating a patchwork compliance landscape to be navigated. If you are involved in your company’s quality, regulatory surveillance, compliance, or knowledge management efforts, the following questions are for you: Do you have frequent (i.e. at least monthly) conversations with the regulators in the markets where you manufacture AND sell? Does your company have the expertise to predict and interpret regulatory directives? Do you have reliable methods of disseminating information on the impact of regulatory directives to your clinical operations teams? How does your organization remain aware of and respond to GxP actions, import alerts, or other market actions against other companies in your industry?
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