"We have a wholly owned affiliate in a Latin American country," explained our GMP Agent-In-Place. "We contract to a local third-party logistics (3PL) provider to store and move our product in that region. From this 3PL, we supply many regional distributors in other countries. The unusual thing is that, 3PL is a virtual affiliate. We have no in-country employees. None of the affiliate officers spend more than a few hours a month on affiliate affairs. Our quality person resides in the US, and handles all the release and review activities from here as only a part of his job. So far, it has worked."
Catch the train"I don't know who develops our products sometimes," our GMP Agent-In-Place complained. "We have some very complex products that are not easy to use. One is a kit with four components; two are diluents, and the other two are freeze-dried materials. The process is to reconstitute the two freeze-dried components first using the diluents provided; and then, with a double-syringe apparatus, administer the product. The double syringe is used to mix the two reconstituted materials at the last second. With this complexity, we receive many complaints. Because redeveloping the product would take years, we sent our experts to the customers and trained them in the product use. Our complaints dropped by 50%. While this seems like great news, when you start with hundreds of complaints per year, cutting them by half still leaves you with more than you care to handle.
"In other cases, with some simpler products, we found that proper training materials helped enormously," our Agent continued. "We have made training video tapes for a couple of products which have reduced our complaints. Some of the videos have been translated into many languages, including Cantonese."
Thanks a million
"Our 3PL received a shipment from our manufacturing site late in the day," began our GMP Agent-In-Place. "I should note that at that time we shipped all of our products in refrigerated trucks (2–8 °C), including our room-temperature products. This procedure saved on freight expenses. In this case, all but one of the pallets on the truck were room-temperature products. The 3PL didn't notice that the last pallet in the truck was a different product that required refrigerated storage, and since it was late, they quickly stored all of the pallets in the 'incoming material' area of their ambient temperature warehouse. The next morning, they realized they had left out the refrigerated product over night, so they called us, clearly upset. They had looked up the commercial value of the product and found that the pallet was worth more than $1 million, and that they were on the hook for it. Luckily for them, we had stability data to support a short excursion at room temperature on this product, so it was usable after all. The 3PL ultimately made some changes in their processing, but the biggest change was one that we made in separating the refrigerated products from the room-temperature products and shipping them separately."
Calculating the loss
"Back in the 1970s, the high-end calculators we used in the laboratories cost more than $100," our GMP Agent-In-Place reminisced. "Items this costly met the company's standard for capital items, so they were tracked. Being a frugal company, there was an annual survey of each department's capital items, and each item had to have its location verified. The location was entered onto a form and then into the computer system. But it's easy to see that calculators are easy to move around, and many times they would be tossed in a drawer and forgotten, or picked up and taken home. In these cases, the manager was chastised for their negligence in the capital loss. Ouch!"
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]