"I was in charge of the vendor audit program," notes our GMP Agent-in-Place. "It was difficult to perform all the audits, and I had this brilliant thought that if I could persuade a senior quality official to do an audit during his next business trip, I could keep the budget down and the audit completion schedule tight.
"When the quality director took a trip, I made sure he had a vendor audit scheduled the day after his meeting and nearby, too, so it wouldn't be hard to find. However, when he got to the location, he was informed that he was at the headquarters, and the actual raw materials site was two hours away. He did the audit at that other site but it was time-constrained more than we had planned."Joe's million-dollar mistake
"We planned to join the many generic firms making i.v. additive products," says our GMP Agent-in-Place. "We were going to be more efficient and cost-competitive by using a form–fill–seal machine and heat-tolerant plastics. We worked for years putting together the specifications for the machines and autoclaves and testing and validating them. The heat-tolerant plastics were tough to manage, so it took longer than expected.
"When the marketing manager who championed the product left, the company decided the market for this product was too small. The project was stopped and the machinery was sold. When I complained to the manager, he said, 'Every senior manager in the company has made a million-dollar mistake. This one was Joe's.'"
Well, how would YOU test it?
"We had a two products that patients frequently complained about the taste of," says our GMP Agent-in-Place. "Even though the product was already opened, our complaint investigator tasted the returned material to try to verify the complaint. I still shudder when I think about it, 30 years later."
"Unbeknownst to us, our stopper vendor had a small problem; and a few wrong stoppers were mixed in with our most recent shipment," notes our GMP Agent-in-Place. "The receipt passed our incoming inspection because the incorrect stoppers weren't found and there were only a few in a lot of 100,000 stoppers.
"An incorrect stopper was seen during filling. At first we thought that the we had mixed up the stoppers during storage, cleaning, sterilizing, or even filling the hopper. So we thoroughly looked at all the records and the handling procedures to see where this could have happened. Every piece of equipment that handled stoppers was examined and examined again. It turned out we couldn't have mixed them up at our factory because the wrong stopper just wasn't processed during a time period when it could happen.
"We sent people to the vendor to work with them and they found a small shelf under the trimmer above the basket that collects the trimmed stoppers. On this shelf, there were a few stoppers held up from a previous lot, which could fall into the current lot. When we looked at the vendors processing records, we found that the lot processed just previous to ours was indeed the wrong stopper and explained our problem. Because we had caught the problem early, we still had possession of all possible vials with the wrong stopper. It turned out that the two stoppers fluoresced differently under UV light, and a 100% UV inspection was performed to pull out those few vials with the wrong stopper. The vendor put a shield over the small shelf to prevent future problems."
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]