"We have some small clinical-style operations that are important to our overall business," explained our GMP Agent-In-Place. "One was located in a professional office/stripmall with shared doors. It turns out that the office next door was empty, and the clinic manager quietly stored 50 boxes of records there. The site owner cleaned the empty office for a prospective client, which including throwing the records away."
Guerilla marketing"A decade or two ago, Wall Street was having a meltdown," our GMP Agent-In-Place remarked. "We had an antacid product in convenient rolls, and one of our innovative salespersons set up a one-person booth to hand out free antacid rolls to Wall Street workers and other passersby. Pretty good guerilla marketing, if you ask me."
"We make a bulk vaccine product in one country that is shipped to another country for filling," started our GMP Agent-In-Place. "The final formulation is made in a big bag on a mixing table that tips back and forth to slosh around the solution. The mixing is supposed to be repeated at the filling site to ensure product homogeneity.
"Similar to many biological products, the product is somewhat sensitive to shears. We damaged the bag in one batch and planned to refilter the product into a new vessel at the receiving site, but only stainless-steel vessels were available. We tried using recirculation pumping to mix the product, but the last few containers that had been filled were highly potent, and had several times the desired strength. This batch was set aside."
"Like many older pharmaceutical companies, ours started with products manufactured from naturally occurring materials. Because our parent company was a meat packer, several of our older products were made with meat parts," said our GMP Agent-In-Place. "After we moved away from the stockyards, we continued to make these products, but with frozen meat parts that were shipped from the packers. The meat packers weren't very careful. We found miscellaneous junk frozen inside, including gloves, more than once. Luckily, this particular product was sold to another company a decade and a half ago."
"I was newly responsible for compliance at a manufacturing site," began our GMP Agent-In-Place. "Soon enough, I hosted my first Drug Enforcement Administration (DEA) inspection. It went all right, but showed how little I knew about DEA rules. So I studied them and realized that companies must report to DEA sales of certain equipment, such as capsule fillers. We had sold one capsule filler the previous year but had not reported the sale. I called the equipment broker to determine whether he knew where the filler ended up. He said, 'I've still got it, do you want it back? I can't seem to sell it.' I declined the purchase, but was then able to send the belated report to DEA. They apparently felt the report was good enough because we never heard from them on this subject."
The right opportunity
"I joined a big, local, old-line pharma company thinking that it would provide more opportunities. But a few months into the job, I realized that there were at least 30% more employees than needed to perform the work required," complained our GMP Agent-In-Place. "The company had started automation projects but was still structured for manual processes. As the manual processes began to phase out, the company had too many employees. I left for a different job just before the old-line company started laying off staff members en masse."
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]