"We sent two batches of the same product to our contracted third party logistics (3PL) provider," sighed our GMP Agent-In-Place. "Both had English labeling, but one was labeled especially for Burma and the other for the US Virgin Islands. The 3PL sent the Burma material to the Virgin Islands. The customer there, a wholesaler, put the product into inventory and started distribution—even though the product had no National Drug Code number and had the wrong lot number. Two days later, the 3PL realized the mistake when preparing the Burma product for sale—there was no product.
"It turns out that the person who picked the product for the Virgin Islands was also the 'checker' for the shipment, and they knew they did it right," said our Agent resignedly. "In the end, we retrieved the incorrect product from the Virgin Islands and sent the correct batch. We also filed a report with FDA regarding the issue."Buggy audit
"I like to inspect bug electrocutors during audits," our GMP Agent-In-Place grins. "I always ask about their choice of installation height. I've never received a good answer. If the light is especially high, I ask whether there are any low-flying or crawling bugs that the device could miss. One auditee asked for my advice concerning low-flying bugs. I told them that the trap should be high enough that the auditor can't see into the catch basin below the electrocutor and take notice that it hasn't been cleaned recently."
"It was in the late 1970s and the toxicology laboratory statistician wanted to automate some LD50 calculations," wrote our GMP Agent-In-Place. "There was an existing programmable calculator on site that he wanted to use. It was about the size of a desktop computer today. The statistician struggled to input the program. It was a week later, after failing repeatedly, that he called the calculator manufacturer and determined that the machine had only 1 KB of memory. The program needed more memory, and for that machine, it would cost thousands of dollars. Today, this problem is hard to imagine given that we can purchase 64 GB for a couple of hundred dollars!"
Check your pipettes
"We buy a product from another company," our GMP Agent-In-Place started. "We received a report from them that the sterile, single-use laboratory pipette tips they used on an pipetter were found to be 1.2% too large. The pipettes were used in one of those funky biological assays, and the assay result was used for an in-process potency adjustment. This resulted in an over potency of 26% (assay is a nonlinear interpolative type). They recalled the product, and so did we."
"Our FDA inspector was reviewing our preventive maintenance (PM) system," noted our GMP Agent-In-Place. "For coolers, she wanted us to ensure that the alarms worked properly during the PM by leaving the cooler door open. In response, we argued that this would be a deviation, and we'd need resolution as it could possibly be an adverse exposure of our products. We further noted (oops) that we had 400 alarms per year, so we knew that the alarm system worked. She thought that was too many, and asked for a summary of the alarms from the Building Management System (BMS). The summary noted 6000 alarms. What a mess! In response to the written finding, we agreed to define some alarms as critical and to check these during PM by changing the electrical signal to the BMS without leaving the door open."
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]