It would TOO have failed
"Don't you love logical people?" grimaced our GMP Agent-In-Place. "When we were validating a computer program, one executed test script failed to meet the criteria for the field having the correct character width. The tester logically deduced that the next test script would fail too, so he logged a failure result into the electronic computer testing system even though it had never been executed. Computer-system corrections were made, and the first test was repeated, passing this time. The second test script was also executed and passed. However, because of the original failing designation, there should have been two executed test scripts (we used a paper-based system). After a deviation report and some counseling of the validation team, we approved the validation report and put the system into operation."
Strike this"Sometimes the story is short," laughed our GMP Agent-In-Place. "During a union strike, our manufacturing manager was driving the company forklift around his department's storage area. He managed to push the forks through a wall into a break-room refrigerator on the other side. Fortunately, no one was injured."
"Can you remember to do something twice a year?" asked our GMP Agent-In-Place. "Our contract distribution company apparently cannot. We have products that need refrigeration during shipment, and we use insulated boxes with gel-packs to provide the cooling. In the summer, we use frozen gel-packs to maximize the cooling. In winter, however, we use mostly refrigerated but not frozen gel-packs. The refrigerated gel-packs provide some cooling, but are mostly used to prevent freezing. When the water in the gel-pack freezes, it gives off a lot of heat to prevent the product from freezing. So twice a year, the pack-out is supposed to be changed to match the seasons, but last October, our contract distribution firm forgot. It wasn't until our audit that we figured out this problem. Our deviation is ongoing," grumped our Agent.
"We received a complaint about small, white plastic particles in our injectable product," noted our GMP Agent-In-Place. "When we investigated the particles, we couldn't identify the particle composition as anything used in the process stream. We looked at sampling devices, tubing, filtration sets, you name it! We visited the complainants to see whether there was additional information regarding how they reconstituted the product that would lead to the creation of such particles.
"During our conversation with the complainants, they noted that the diameter of the opening of the aluminum seal after the plastic flip top was removed was small compared with the diameter of the white plastic spike that we provide to transfer the diluent from the diluent vial to the freeze-dried product vial," our Agent continued. "We asked them to demonstrate how they reconstituted the product. The customer angled the spike into the vial, scraping the spike along the aluminum seal, and pushed the scrapings into the vial as they continued to insert the spike fully. The white plastic contaminant particles were part of the spike. We proceeded to provide hands-on practice using the proper technique."
What a sight
"Our product was a once-a-day time-release capsule," described our GMP Agent-In-Place. "But unlike the usual beads, inside the capsule were several three-layer tablets. The exterior layers were wax-like and did not dissolve; the time-release action was produced by the active ingredient moving sideways through the tablets.
"Several patients complained that the product did not dissolve and that they weren't getting the full dose. When we asked how they knew this, they noted that there were carcasses of the three-layer tablets present in their feces. We explained that the wax-like layers would not quickly dissolve and may pass intact through the digestive tract and that this wouldn't result in a lack of efficacy. A couple of them sent in evidence for our analysis," grimaced our Agent. "We began calling such complaints 'sighting reports.'"
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]