USP Concerned About Shipping
Regulators are growing more concerned about mishandling of pharmaceuticals during distribution. As a result, manufacturers must be better prepared to monitor their distribution environments, a consultant told attendees at a recent conference.
Many of the problems occur after the product has been transferred to the wholesaler, distributor, or other third party, said consultant Linda A. Walker at the SouthPack conference, held in April in Atlanta. However, she said, in the end it may be the pharmaceutical manufacturer that bears ultimate responsibility.
"Third-party shipping is a source of great concern for the USP (United States Pharmacopeia; Rockville, MD) and FDA," she said. "It is causing USP to look very carefully at mail-order drug fulfillment, for example. However, FDA cannot look at wholesalers. But they can come down on manufacturers.
"FDA is asking to see a lot more shipping data than it was even two years ago, especially if [the product] is a vaccine," she explained. "CBER (the Center for Biologics Evaluation and Research) is especially meticulous. CDER (the Center for Drug Evaluation and Research) will ask if you have the data. CBER will ask to see it. But we are starting to see CDER get more interested as well."
Some pharmaceutical companies may believe they don't have to monitor shipments, as they have already qualified the containers being used. Walker said this can be a valid argument, as "subsequent mishandling can cause a failure unrelated to shipping events," so shipment monitoring will not guarantee that nothing will happen to the product. "The highest risk of out-of-range conditions occurs in storage and handling after receipt," she says.
However, she said, because most pharmaceutical products are expensive and many can cause risks to patients if something goes wrong, it pays to do some sort of shipment monitoring program. "Good packages can and do go bad," she said.