"This worked fine until one day, the chromatographer was out of the lab. I went to his side of the bench and found the sample. When the assay was run, the result for the positive control was horrible! When the chromatographer came back, I told him what had happened."When he asked me which bottle I used, I replied, 'The one we always use.'
"That is when he walked me over to the bench and showed me two identical-looking bottles—one on one shelf, the other on a different shelf. When I pointed to the bottle that was used, he promptly told me, 'Oh, that's not the one I usually give you.'
"Both bottles were labeled exactly the same, except for recovery weight! The chromatographer explained that the chromatography peak that produced the sample was very large, and when dried it wouldn't all fit in one bottle. So one bottle contained the front half of the peak, while the second bottle contained the second half of the peak."
"It was a standard industrial-scale chromatography purification station, with gleaming stainless steel and well-placed instrumentation," explains our GMP Agent-in-Place. "We really knew what we were doing—until we opened the column for a routine repacking.
"When the column was opened, there were a couple of durable laboratory wipes—you all know the ones I mean— laying on top of the resin! They could have been there for several column runs.
"Evidently, the wipes had been used to clean the bulk vessel and then were forgotten. Then, when the vessel was filled and the solution pumped through the connecting hose into the column, the wipes were pumped along for the ride. I started hating the word 'REJECTION.'"
"I wish I knew who did it," gripes our GMP Agent-in-Place. "And even now, years later, we don't know whether it was a labeling mistake in the pharmacy department or an error in selecting the correct material in production. The result was that an incorrect salt compound was used to formulate the chromatography wash buffer.
"After loading the chromatography column, the misbegotten buffer was applied, and the product precipitated in the column. What a mess!
"Both the product and the column had to be rejected and destroyed—a half-million dollars down the tubes and no one to blame."
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 [email protected]