It's de nature of the thing
"We bought a product that was made in the US, and are moving it to our European manufacturing site," reported our GMP Agent-In-Place. "Because we make a similar product, we assumed it wouldn't be much different. However, one of the processing aids for the new US-based product was denatured alcohol. We replicated the processing aid with local-source denatured alcohol rather than paying to transport US-manufactured alcohol (not to mention dealing with the cross-border alcohol laws).
"It turns out," our agent continued, "US denatured alcohol (3A) uses methanol as a denaturing agent. Our local denatured alcohol uses methyl-ethyl-ketone, and this made a big difference in the final product. The ketone was concentrated with the product during processing, rather than being washed off in the purification process as was the methanol, so the first test batches were unusable for licensing the new manufacturing site and had to be destroyed."Stressed out
"One of our new vessels developed a leak near the bottom," groused our GMP Agent-In-Place. "It took some analysis, but we discovered that the magnetically coupled stirrer slowly stressed the nearby welds, which then cracked and caused the leak. I was proud that we not only fixed the vessel and inspected and reinforced others on the site, but we also made sure that all similar vessels at our other manufacturing sites across the ocean were inspected and reinforced as needed. That's a good preventive and corrective action program in action."
The dog ate my homework
"One of the products we distribute is manufactured by another firm who also owns the license. However, we do the packaging and labeling," our GMP Agent-In-Place began. "Our contract stated that we needed the other firm's written approval of all labeling and marketing materials. We thought we had a good system for managing this task. However, when the firm asked to see the approval for a particular marketing campaign, no one could find it. The firm is seeking a public repudiation of the advertisements that went out. Our negotiations are still pending."
"Because I have a lot of experience in hosting FDA inspections and in auditing international sites, I was asked to help prepare our European site for a preapproval inspection," bragged our GMP Agent-In-Place. "I had just begun the preparation when all of the contact personnel were pulled away. The site had a media failure and all available hands were needed to address it and the consequences. Because I had traveled 3000 miles to get there, they provided a junior quality-division employee to walk me through the documents. Ultimately, there was not enough information available without the staff and I had to come back three weeks later."
Over the years, I've had a variety of quality-based initiatives thrown at me (see list below). I'd like to hear your experience with them. Some are so old that I've forgotten what the acronym stands for.
Send your thoughts to [email protected]
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]