Knowing is Half the Battle

Published on: 
Pharmaceutical Technology, Pharmaceutical Technology-09-02-2011, Volume 35, Issue 9

Being aware of a forthcoming inspection or how a product was made can make a huge difference.

It's cheaper to give than to sell

"Some countries require audits before approving a product for their market," noted our GMP Agent-In-Place. "They also require the host company to pay for the audit and travel expenses. So when our favorite Southern Hemisphere country audited, the bill was $200,000. Two years later, we had sold a total of 15 vials of product in that country. Whose idea was that anyway? We should have just made a gift of the vials."

Preparation is key

"We had a central computer system in use around the world at all of our manufacturing sites," our GMP Agent-In-Place began. "It's location was in the United States. A foreign inspector wanted to see the hardware and hardware qualification documents, so he visited our site. Because such inspections are scheduled, we had a chance to retrieve and review all the pertinent records. Key employees were well briefed in their explanations, especially where there might be difficult questions.


"One potentially difficult topic was training because some employees with impressive longevity had been grandfathered for certain activities, and had no training records. When the inspector asked for a training record, he didn't specify a position or person, so we naturally handed him a new employee's folder with a complete record. It's these little things that can make a difference. We ended up with no findings."

I made that

"Fifteen years ago, I was traveling to Brazil for a meeting with some of our affiliates," recalled our GMP Agent-In-Place. "Before traveling, I had to get a couple of immunizations, so I went to a travel specialist medical group to get them. One required injection came in a vial. The nurse flipped off the seal and was going to stick the syringe through the stopper without disinfecting the stopper. I yelled, and requested her to stop and disinfect the stopper first. After a discussion, it was clear that she thought the stopper was sterile, but I knew that the seal was merely a dust cover. Yes, the stopper starts sterile, but the flip-off seal does not assure sterility. How did I know this, you might ask? The product was one that I made."

I made that, take 2

"For me, it's always fun to have the products I help make administered to me," smiled our GMP Agent-In-Place. "I know the adverse-event profile and complaint profile, and I can hold a productive discussion with the healthcare professional. Some time ago, I was at the eye doctor and he used some orange-dye strips. I had made them and we had an interesting conversation about them. There's a certain comfort level knowing all of the steps we had taken to assure the product's identity, safety, potency, purity, and quality."


"At my previous company, there was a huge emphasis on cost savings," our GMP Agent-In-Place reported. "I ran the stability program and, every year, the director of quality would ask whether I had any savings for him. The first time he asked, I wasn't sure how to answer, but he explained. Anytime that we canceled a stability test or discontinued a program, these were savings, and we should total them up.

"After that meeting, our team regularly determined whether we needed to perform all the post-expiration date testing that had been requested. Another fruitful area turned out to be testing that was requested by certain development project managers—often, the first lots were left in stability testing areas well after the product's development had moved on; these early lots were no longer needed. A few years later, I was informed that these savings were directly related to the bonus the director received. Non-directors did not qualify for such a bonus."

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