Unapproval confession
"It was only sheerest chance that we discovered it at all," notes our GMP-Agent-in-Place. "It was in the late 1980s when we
manufactured a timed-release bead in a capsule product that was manufactured with an active ingredient from a supplier that
was not in the new drug application and therefore was not approved. We had sold several batches of the product.
"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
"We had produced this ophthalmic preparation for a long time, and when one adverse event for 'burning sensation' came in,
we thought nothing of it," admits our GMP Agent-in-Place. "But when similar reports of adverse events came pouring in, we
nearly panicked. This was a well known, well-understood formulation, and we didn't understand what could be causing these
reactions.
"Finally we decided to matrix all the ingredients used in all the recent batches, whether or not there were adverse events.
This process led us to determine that the common factor was a plastic resin used for making the bottles of one product. Further
investigation into the matter told us that the supplier had changed the colorant in the resin without notifying us. As a result,
we recalled the affected product and trashed two months of production!"
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?
"Wrong.
"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."
Pharmaceutical Technology's monthly "Agent-in-Place" column distills true-life cautionary tales from the secret files of Control, a senior compliance
officer. If you have a story of clueless operators, oblivious management, inopportune lapses of judgment, or Murphy's Law
in action, please send it to Control at AgentinPlace@advanstar.com
. 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.
