Requirements for wholesale distributers, repackagers and pharmacies will take effect on a staggered basis between 2017 and 2023. There aren’t many requirements for manufacturers after 2017, except to work with the FDA and the rest of the industry to figure out what will happen in 2023 with the shift to a new type of security system. However, as a practical matter, there will likely be a lot of work done to continue to improve and streamline all these new processes, adopt additional automations, and begin preparations internally to do the necessary implementations that are coming in 2023.
The USDM Life Sciences Track & Trace Solutions and Services team will help you assess, plan and execute the changes and enhancements necessary to meet these regulations. Our team of experts will assess your products, the markets where they are sold and determine an implementation strategy for the changes that need to be made. USDM’s assessment methodology is extensive and includes the labels and packaging, the management of identification changes to each product, the changes to PLM, ERP, EPCIS and packaging systems, changes to printing, vision inspection and warehouse/inventory management systems and interfaces to foreign medical agency databases for pharmaceutical tracking. Also, USDM experts ensure that all changes and enhancements are implemented under the governing GMP regulations, under change control and validated prior to release for production.
No comments:
Post a Comment