"We were using a new electronic system to manage our deviations that arose during the validation of our ERP (enterprise resource planning) computer system," explains our GMP Agent-in-Place. "The electronic deviation system was new and we hadn't thought its use through completely. The deviation system had only one main field into which a user could enter the corrective actions and also the verification of these actions. However, sometimes, these two applications would contradict.
"In one case the corrective action was 'Added a step to the data migration plan.' But later, in the same field but entered by a different user, the comment read 'Data migration plan cannot be run as amended,' and then the deviation was closed. When asked about this problem, neither of the system users could state what was done with the data migration to make sure it was right, nor whether the migration plan eventually worked as amended or if there was another adjustment made to successfully move the data. What a mess! Eventually, the data were verified independently as being moved successfully, but we still don't know how."Oil tracks
"During the filling of one of our products, the operator noticed an unusual oily smell," says our GMP Agent-in-Place. "The smell was later confirmed by the laboratory, and the product was quarantined. A different product that was manufactured about the same time also was noted to have the same oily smell, so the effect of the problem had gone to critical in a day.
"Many possible sources were investigated, but it was eventually tracked down to coming from the alcohol used in the process. The alcohol is a process aid that later gets removed, but apparently it had transported oil from the source to the product in the meantime. It turned out that the alcohol distillation equipment had been recently refurbished, and new metallic boiling beads were installed. These new metal materials had not been cleaned before placement, and so they still had their protective coat of oil on them, which was ultimately transported to the product. It had been quite a lot of detective work, and ended up with several final product batches going to the landfill."
"We had gutted the tablet manufacturing facility to provide for a new product," recalls our GMP Agent-in-Place. "One of the improvements was new air handlers and ducting. We were about a week away from start-up and getting anxious. The contractor turned on the air system for first time, but the fan was placed backward and it sucked air instead of pushed it. It collapsed most of the metal air ducts. The contractor was able to replace the ductwork, and turn the fan around, in time for our planned opening."
Lost in the family?
"Thirty years ago we had a regular FDA inspector from the local field office, so we got to know him pretty well," says our GMP Agent-in-Place. "During one visit, my boss told him there was a relative in the factory that he should meet and brought in a factory worker with the same last name but was obviously a different race. The joke backfired when the inspector stood up, hugged the factory worker, and called out, 'My brother, how have you been, we thought you'd been lost!' The factory worker was embarrassed, and so should have been the department manager."
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]