Ensuring Supply Chain Safety
This article discusses security and data integrity in the Supply Chain, with a focus on suppliers (domestic and foreign). The article does not center around cold chain specifically, but data integrity is very relevant to cold chain related records as well; it also provides interesting statistics on data integrity related regulatory actions:
Data integrity and cGMP issues demand closer scrutiny of suppliers. Bribery and corruption may become the next supply chain flashpoint.
In the 12 months ending June 1, 2016, he notes, FDA issued 25 warning letters to pharmaceutical manufacturers, and, excluding compounding and marketing-related actions, 23 were issued to foreign facilities. “We’ve reached the point where 90% of warning letters are being issued to foreign facilities, many of which are in India and China,” Farquhar says. Considering that approximately 80% of the pharmaceuticals sold in the US are either made overseas or use APIs that are made offshore, he adds, “that’s a huge percentage of distribution.”
His colleague, Hyman, Phelps and McNamara lawyer and FDA alumnus Mark Schwartz, notes that data integrity is most often cited in warning letters to offshore suppliers, accounting for 43% of FDA’s Center for Drug Evaluation and Research’s (CDER’s) warning letters in 2011, but 78% of warning letters in 2015. Chinese and Indian manufacturers were cited in 31% of warning letters in 2011, he says, but four years later, that number had risen to 70%.