Source: Pharmaceutical Technology
Issue 1,Volume 35
Multiple attempts and do-over approaches should eventually solve the problem at stake.
"Our retain samples were stored in those grey metal, World War II-era, 6-ft tall storage cabinets," began our GMP Agent-In-Place. "Like many places, we used the cheapest storage area we could find, which was a basement area under the sterile suite. The autoclave drains traveled above some of the cabinets, and they started to leak.
"Of course, we did the obvious, most expedient thing to solve the problem. Several of us pushed the full cabinets around the room by hand so they wouldn't get leaked on. Unfortunately, one employee ended up with a hernia from this process."
"We run one of our processes 365/24," explains our GMP Agent-In-Place. "We have a tank farm of 10 vessels we use, and we start the process anew when a vessel becomes available. A consultant who had been hired to look at data on the manufacturing floor noted that there was some slack time in vessel usage, and pointed this out to management. He was assigned to evaluate whether we could increase throughput without purchasing a new, expensive, and long lead-time vessel.
"After a couple of weeks in the manufacturing area with a stopwatch, he reported that if we scheduled the vessels carefully, we could gain a 10% throughput without additional equipment. Although we didn't quite reach that elusive 10% goal, we did increase throughput relatively painlessly, without the additional costs."
"Our company's management realized that we would need a significant amount of additional packaging employees during the next two years for a special project, but expected the headcount demand to reduce after the project was done," our GMP Agent-In-Place sighed. "To keep costs and Union membership down, they hired the workers for staggered six-month terms. After six months, the worker was let go for at least six months. Each year, we had to hire and train hundreds of temps.
"As quality supervisor for product inspection, I kept a tracking chart for packaging errors. I pointed out to management that as soon as this temporary employment wave came through, the packaging chart error rate quadrupled," said our Agent.
"We use a bunch of acronyms that are near to our hearts, and I want to share them with you," our GMP Agent-In-Place noted. "They include: template blindness, which refers to when we gave our affiliates a templated standard operating procedure to use as a starting point for their internal use, but they just signed the template.
"SQUIPP. This abbreviation stands for Safety, Quality, Identity, Potency, and Purity. It is typically used in risk statements such as 'SQUIPP wasn't affected.'
"A deviation is a deviation is a deviation. This phrase means that you shouldn't have six separate systems defining deviation investigational process such as stability failures, environmental monitoring excursions, out-of-specification test results, product complaints, sterility failures, computer incident reports, and validation deviations.
"EMCAR. This acronym stands for Environmental Monitoring Corrective Action Report and contains the root cause, risk analysis, and corrective actions for an environmental-monitoring excursion.
"CAT. The acronym refers to Corrective Action Transfer, denoting a link between a completed and closed deviation investigation and a long-term corrective action that will be tracked by a separate system."
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 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.