"IT's nearly hopeless," said our GMP Agent-In-Place. "We had a local information technology (IT) quality-management system (QMS) at our headquarters. It was pretty basic, but we had one. When we started developing a global enterprise resource-management system, we decided we needed a better global QMS, so we put one into place, but only for the enterprise management system. After a while, we thought we wanted a better global IT QMS, and started to develop one. So we had the various site IT QMS in use as well as one-and-a-half global QMS. When we started a new major global IT project, we didn't know which QMS to use. Since we couldn't wait for a new, perfect global QMS, we wrote another software specific version. Arrrgh!"
If you snooze, you lose"Among our various products were some older ones we didn't pay much attention to," our GMP Agent-In-Place explained. "Because we made so few batches, and they were not in our focus product lines, we sort of forgot about them. The US Pharmacopeia (USP) published proposed changes to the dissolution requirements, and we didn't check whether the changes had any effect on our product," added our Agent. "Ultimately, USP published a final monograph that our product didn't meet. We could either label the product 'not USP,' or discontinue production. It's nice when USP helps prune dead wood from your product line."
"Occasionally, we took advantage of our positions in the laboratory," said our GMP Agent-In-Place. "Since we order product samples for testing, retains, and stability, we often received too many samples, especially of vitamins and over-the-counter pain relievers. We referred to the extras as 'use-test' samples and took them home for personal use."
"During some planned welding in our coldroom during shutdown, our maintenance manager wheeled in a large dolly fire extinguisher 'just in case,'" recalls our GMP Agent-In-Place. "The stairs and the associated handrail needed repair (the handrail was a hollow-pipe rail). We used alcohol extensively in the production of our products, and apparently it seeped into the handrail, pooling at the lower end, and because it was a coldroom, there was not much evaporation. The welder opened up the end and the alcohol poured out—in flames. Fortunately, the maintenance manager—who happened to be supervising the work—quickly extinguished the fire."
Insert this fast
"For many new products, the last item to get approved by the US Food and Drug Administration is the product insert," explained our GMP Agent-In-Place. "Sometimes it's our own fault for not following the guidance, and we get called on it. In one case, we had the product made and packaged—except for the insert. After we got the insert approval, we didn't want to wait an extra week to get the inserts printed. So we made photocopies in house, hand-folded them, and stuffed them into the first two shipped batches."
Wait for it
"I love FDA stories," said our GMP Agent-In-Place. "I wish more readers would send in their favorites. In one of the inspections I hosted, an FDA investigator was reviewing a validation study and asked for the standard operating procedure (SOP) used to collect the data on the page. Not wanting to lose her place, she put her finger on the paragraph and waited for the SOP. This is a 1-million-ft2 factory and things take time to retrieve. She was angry (and still waiting with her finger poised) when the SOP got to her 30 minutes later."
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]