"According to the batch record, the operators had added the correct amount of B12. There was even a second weight check in
the manufacturing area, and it reported in-specification results.
"But when we finally got to the dispensing records, they told another story—somebody had put ten times more cyanocobalamin
into the recipe than they were supposed to. Sure, a ten-fold error sounds like a lot, but B12 is added in such small quantities
that nobody could catch it visually."
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.
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