Correlation may be causation

"I thought it was merely coincidence, but the head of marketing thought it was the problem," our GMP Agent-In-Place began. "I work in a small specialized subset of the pharmaceutical industry, and I received a call from a former colleague. It turns out he had recently joined a competitor company. He had a question regarding shipment of our common raw material across the ocean. His company was missing a temperature monitor, and wondered how we would rectify such a situation. Because this was a generic regulatory question, and didn't relate to any trade secrets, I provided the information.

"A week later, the head of our marketing organization called me regarding one of our products," chuckled our Agent. "Apparently our main competitor in this product area was no longer supplying the market and she wondered whether there was a way we could get batch approval faster for our product to prevent shortages. It turns out that the competitor was the one I talked to the previous week! I mentioned this, and my marketing colleague immediately grasped this as the reason for the competitor's apparent production issues."

"In last month's column, I noted that we discovered that a filter could perform a secondary task," our GMP Agent-In-Place grimaced. "Guess what, we've got another one. In this case, it is a viral-removal filter. It operates by having such small holes that viruses must stay behind and let the product pass through. After we tried to change it, we found out it also removed some heavyweight polymers. The product failed release testing, so we had to perform further work on the process before we could change the filter."

Ask forgiveness, not permission

"We instituted an intensive change-control program," boasted our GMP Agent-In-Place. "We educated the staff, especially the maintenance shop staff, to run any change to a product contact material through the change-control process for evaluation. We thought things were running smoothly when the maintenance supervisor said that the production staff wanted to change a tank gasket from Teflon to silicone. When we looked into this, we discovered that the gaskets were traditionally purchased by the production staff for replacement by contractors during shutdowns, and they had already made the switch. They wanted maintenance to carry the gaskets for emergency replacements and the next shutdown.

"After initiating a deviation for the failure to follow the proper change-control system, we performed a post implementation evaluation, including a risk analysis and extractables studies," noted our Agent. "The risk was minimal because these particular gaskets are placed above the liquid level and rarely have product contact. Any product contact is fleeting, and seen as little risk. The extractables and leachables were well within allowable limits, but they should have been checked first."

Audit the auditor

"I've been in quality my whole career," our GMP Agent-In-Place said. "This past year, I was asked to work on a quality system for a US-based marketing organization. We have a global policy about this, so it wasn't hard to do. A year later, we were audited. Our standard agreements specify that the manufacturing sites could audit us annually, but in my 35 years they never had, until now. I really made the auditor mad when I told her that I had no intention of changing practices, and that any observation she gave me would get the answer; 'We shall continue our current practice.' As a result, she took this minor issue and cited it as a major failing, needing a higher level oversight and correction. It was funny at the time, now it's an irritation."

Pharmaceutical Technology's monthly "Agent-in-Place" column distills true industry 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.