"Our throughput of clinical samples was huge, and although we had large-scale test automation, our projected volume increases overwhelmed our laboratory," began our GMP Agent-In-Place. "The solution was to install a higher level of automation that contained custom sample handling equipment and automatic aliquoter equipment. The new system would allow us to receive one sample and perform our standard battery of tests. Because we needed to keep production going at the same time as the new build, a new site was selected. The new build was successful, however, our trained laboratory analysts are now simply pushing carts full of samples and loading machines. Everything else is automatic. I wonder when they will realize that their new role is well below their skill level?" wondered our Agent.
All broken up"At the end of a shift, a 10-year experienced operator delivered to his manager a cracked and broken glass graduated cylinder for replacement," reported our GMP Agent-In-Place. "He explained that early in his shift, he had dropped it on the floor and it had broken. When I asked the operator what he had used to take in-process samples all day, he said 'that broken graduated cylinder.' The operator explained that there was enough left of the graduated cylinder to take an adequate sample, and because the samples are rejected after testing, he thought it was OK to use the broken glassware. It never occurred to him that he was reaching directly into the batch to take samples, potentially contaminating the product with glass. The result was rejection of the $25,000 batch."
"The head of our company's scientific department had all the right job qualifications," noted our GMP Agent-In-Place. "He had an MD, a PhD in biochemistry, and a JD. He took a tour of our facility one year, and took another tour two years later. During the second tour, he asked that I point out to him any new equipment. I thought I had it covered, but I was really sweating when he pointed to a box that was only partially visible from the doorway and said that it was new. It was a new PLC used to control labeling on the packaging line. I had overlooked it, and evidently, he had a photographic memory."
A need for speed
"We had a multistep packaging operation in which the downstream equipment was significantly slower than the blister-card thermoformer at the start of the line," described our GMP Agent-In-Place. "Operations had been running the thermoformer at the qualified speed until the line was full, at which point, they would shut it off and wait for the downstream equipment to catch up. Once the line was nearly empty, they would turn the thermoformer back on and restart the cycle.
"When new management instituted an efficiency metric," our agent groaned, "the thermoformer showed poor results because of this 'stop-and-wait' approach. To improve the metric, we were told to run the thermoformer slower—at the same speed of the downstream equipment. So, engineering set up a line trial to qualify a slower run speed, but the qualification failed. The difference in speed correlated to longer contact time with the heating plates, which caused a product-quality issue and seal-quality issues with the blister card. During the next 10 months, engineering, validation, and quality assurance personnel made equipment modifications, spent $15,000, and conducted several line trials in attempt to qualify the slower speed. In the end, the total capacity and units packed per hour on the line remained unchanged."
Pharmaceutical Technology's monthly "Agent-in-Place" column distills true-life cautionary tales from the files of Control, a senior compliance officer. If you have a story to share, please email it to Control at [email protected]