As pharmaceutical companies continue to grow, they are relying more heavily on contract manufacturers. According to “Better by Design,” Doug Bartholomew’s article in Pharmaceutical Manufacturing, pharmaceutical companies have been moving 30% to 50% of their manufacturing to contract manufacturers over the last few years. Outsourcing to a CMO reduces costs and increases manufacturing capacity.
The problem, however, is that quality and safety are at risk because there isn’t a standard method of communication and CMO management. Failing to properly manage a supplier, in fact, is grounds for an FDA warning. Pharmaceutical companies are struggling to keep up, though, because they are not receiving the same level of data on outsourced product as they do on those they produce themselves. This is the result of inconsistent information sharing between companies and their many suppliers.
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