All the Wrong Questions

Getting an answer is easy—asking the right question is apparently more difficult.
Jul 02, 2011

Banana splits, anyone?

"We validated it," our GMP Agent-In-Place swore. "We received test syringes and ran them through the labeling machine. They worked perfectly. But the manufacturing setup mechanics must have set up the labeling equipment incorrectly. There was so much breakage. It is an expensive product, and the breakage meant lost income and delays. The investigation started with a call to our European colleagues who use the same syringe. In fact, the validation quantities had come from their stocks. We were unaware that new syringes had been manufactured by a North American factory, rather than by the European syringe factory," moaned our Agent. "The North American syringes were actually banana-shaped, with a bit of a curve. When they were rolled along the labeling machine, pressure caused the breakage. Our validation had used the 'best-case scenario' syringes."

Objective inspection

"At the end of the year, we filled out our self-evaluation forms based on year-long objectives," our GMP Agent-In-Place sighed. "Among other things, I was responsible for hosting inspections, but that duty never shows up on the objectives list because it is essentially a job-description requirement. I was upset because I could only demonstrate that 20% of my objectives had been reached. When I added up the inspection days I spent with FDA, the US Drug Enforcement Agency, the US Bureau of Alcohol Tobacco and Firearms (we used 1 million gallons of denatured alcohol per year, and they want accounting for it), the US Department of Agriculture, and health authorities from Germany and the United Kingdom, however, I realized that I had been involved in 202 inspection days."

On the bubble

"One thing I like to check when auditing is whether the balances or scales are level," began our GMP Agent-In-Place. "Most of them have a bubble indicator, and the bubble should appear inside the circle for proper operation. You'd be surprised how often I find the scales off level. After moving a scale, good practice involves performing at least a two-point check with certified weights on the scales and balances. A best practice is a full recalibration."

Helping out

"Sometimes we get involved in activities outside our department, even if it is just answering a question," our GMP Agent-In-Place explained. "We had a new employee who was responsible for the safety program. A woman from the research and development division hurt her back while lifting a product container. We use metric measurement for everything, and the safety manager was used to American-standard measures. He didn't realize how much 60 L of product would weigh when we told the woman she could move it—it actually weighed about 140 pounds (given the density of the material). The container was a large bulky item for anyone to be lifting and repositioning."

Budgeted compliance

"Site projects were often prioritized by the site manager," noted our GMP Agent-In-Place. "The goal was to move projects forward based upon compliance and quality at each site, so after a year of politicking, we had a $200,000 budget for use in unplanned quality projects at the discretion of the worldwide vice-president for quality. One site head read the budget in full, and as soon as the new budget year began, he requested funding from our stash. He wanted to paint hallways and the guardhouse, claiming that the result would be improved morale which would ultimately improve quality. The request was rejected."

Substandard substrate

"Ouch," winced our GMP Agent-In-Place. "Our contract manufacturer owns the product license and decided that we had to recall several batches of product. The product was sold based on the potency in the vial; more potency means higher prices. The potency is labeled on the vial and differs from batch to batch. On the recalled batches, the potency was too high. When we asked why the labeled potency was so high, the manufacturer explained that they had changed the assay substrate, and it was resulting in a higher potency than desired. Simply put, we had failed to properly validate the method change."

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
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