"Once we discovered this, the new supplier was qualified, and a supplement to the new drug application was submitted and ultimately was approved by FDA. However, the batches made with the unapproved supplier were never recalled and were left on the market!"You can bet that we reviewed every supplier we used against the new drug applications and issued a formal list of the approved suppliers and ingredients. We also instituted a check of the supplier and ingredient list as part of the material receipt process."
Eye feel your pain
Something's fishy here
"The problem was just ordinary salt—that's right, sodium chloride," relates our GMP-Agent-in-Place. "Production volumes had increased, and our purchasing department had fallen behind in the orders for the injectable-quality salt we needed. So they had five drums air-shipped in overnight for immediate use while the main shipment was being prepared. Problem solved, right?
"When the salt was received and the drums were opened for sampling, one smelled fishy. Apparently the drums had seen previous use! While the laboratory testing all passed, the smell alone was enough to reject all the drums, and another overnight air-shipment was required. They always blame the quality department, but we didn't order our ingredients to be shipped in used drums. Production was shut down for 48 hours because of the lack of salt."
. We won't use any names, but if we do use your tale of disaster, courage, or just plain weirdness, Control will send you a coveted Pharmaceutical Technology t-shirt.