How To Risk Manage Your Contract Manufacturers and Packagers
Almost all drug manufacturers make use of one or more contract manufacturers (CMO) and/or contract packagers (CPO) to package at least some of their products. One of the things drug manufacturers rely upon their contract organizations to provide them is the ability to comply with the labeling regulations of the markets they sell into. That means CMO and CPOs must keep their packaging capabilities current with the regulations in those target markets, or they may see a loss in business when regulations become more complex.
Serialization regulatory deadlines have either passed, or are approaching in four of the top five pharmaceutical markets in the world and more are established each year. Companies that offer packaging services to major drug manufacturers must develop and follow a program of adding multiple serialization-related capabilities to all of their pharma and biologic packaging lines within the next 18 months, or risk losing a significant percent of their business to competitors who already have implemented an industry standard strategy. Drug manufacturers will have no choice but to move their business to vendors who are able to keep them compliant.