Compliant or Contraband?

It's customary

"We had the usual 'manufactured by' statement on our imported product," our GMP Agent-In-Place moaned. "But it turns out that US Customs did not think it was clear enough, and we had to add a 'made in foreign country' statement as well. As a result, the product in our inventory is now considered violative and needs a sticker to be brought into compliance. We are wondering about other import–export rules that we are unknowingly breaking, and have hired full-time employees and consultants to work on this for us."

Icy change

"The best laid plans can go awry," sighed our GMP Agent-In-Place, "We had a new refrigerated product shipper that we planned to use, and had everyone sign off on the implementation plan, which included dates. Based on that agreement, our logistics crew had stopped ordering the old shippers and gel packs in favor of newer products. When the sales department requested a delay in the roll-out a couple of weeks before implementation, we had an inventory shortage. We were able to get additional supply of the old shippers, but the gel packs weren't readily available in a frozen state. A pallet of gel bricks can take a month to freeze. We ultimately used larger bricks that the distribution center had on hand as replacements—based on a theoretical cooling capacity calculation—for a couple of weeks. We wrote it up as a deviation."

Spotty quality

"When the first batch of lyophilized product came out of our new lyophilizer, it was noted that many stoppers had brown spots on top," our GMP Agent-In-Place said. "Our investigation took a considerable amount of time, but the analysis of the brown material resulted in its identification as a stainless-steel polishing agent. Apparently the cleaning was insufficient, and some polishing agent remained under the shelves, and since we couldn't be sure that a visual inspection would catch all of the potentially contaminated stoppers, we completed a thorough medical evaluation. Based on the miniscule amount of polishing agent that might be pushed into the product vial by the needle, and the low level of agent toxicity, it was determined that the remaining vials could be sold."

Management by clothing

"In the 1980s, we required our supervisors to wear ties at work," chuckled our GMP Agent-In-Place. "This was clearly prior to the current business-casual environment that most of us work in nowadays. One of our supervisors was in an argument with a line employee in packaging, and used his tie to emphasize his superior position and enforce his argument, stating, 'this tie talks.'"

Variable labeling

"We liked the idea of Life Savers candy assorted-flavor and color-roll pack," began our GMP Agent-In-Place. "So for our over-the-counter product, we bought some equipment and rolled out production. Instead of buying the same sort of equipment that Life Savers used (which assured each roll had the exact same assortment of flavors), we merely mixed and packed the tablets. Therefore, any given roll was filled with random tablets and could have any mixture—including all of one flavor. When this was pointed out by our quality staff, we had to change the labeling. We could only state that the roll 'may' contain the flavors, not that it did contain all of them."

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 AgentinPlace@advanstar.com. We won't use any names, but if we do use your experience in the column, you'll receive a Pharmaceutical Technology t-shirt.