But the label looked great
"Our purchasing agent thought that the new label technology was great after hearing a roll-label salesman's enthusiastic pitch,"
gripes our GMP Agent-In-Place. "The new technology was an upgraded sunscreen protection for the labels for products that might
be stored in direct sunlight. The labels would not yellow under ultraviolet light. With a simple flick of his pen, all new
label orders included this technology, and the purchasing agent had once again 'saved us' and improved our competitive position.
(Note that I didn't say the change was evaluated within our change control system.)
"Now fast forward a bit: The labels arrived and were put into use. During a routine surveillance sampling project, FDA took
samples that had the new labeling for one of our big sellers. FDA's tests showed an unusual contaminant inside the bottles:
It was the new UV protective coating that was on the label!
"An investigation showed that our product had such an affinity for the label's UV protective coating, that it 'sucked' the
chemical through the hard-plastic bottle. In the end, we destroyed a big pile of labels and put an emergency order in for
labels made out of the original composition."
Over-ride 'em cowboy
"The packaging supervisor walking through the packaging department noticed that operators on Line 2 were repeatedly pushing
the 'over-ride' button for the carton bar code reader," our GMP Agent-in-Place reports. "When she examined the cartons, she
found that the 50-mL product size was being packed off into 100-mL cartons and that the 'over-ride' button had been pushed
more than 150 times! Fifteen cases of 10 bottles in the wrong cartons had been packed into shippers.
"The operators thought that the set-up mechanic had made a mistake in setting up the bar code reader. It was locked and they
couldn't reset it, but they could over-ride it. The operators reasoned the packaging materials had been ordered and received
from the warehouse, the packaging line had been precleared, the materials checked by production, and double checked by quality
assurance onto the packaging line, and the line was set up. Even the bar code challenge was double checked, so the cartons
must be right.
"It turns out that the cartons for the two sizes of product were remarkably similar: nearly the same size, identical in coloration,
with only differences being the given volume, one digit in the NDC (National Drug Code) number, and the carton bar code.
"Four different people made the same mistake! Each unknowingly depended on the others to do the job right."
Unravel this roll
"During a meeting with our major stockholders and investment firm representatives, the company president handed out samples
of our new roll packages of our primary over-the-counter product" recounts our GMP Agent-in-Place. "As he was giving them
out, the outer label fell off.
"When the president got back into the office, he was livid. He called the head of quality into his office and gave him a good
haranguing. It turned out that the poor label-adhesion problem was also noted during packaging, but because the label appeared
to adhere well enough to make it through the sales process, no actions were taken at the time. The head of quality had approved
this 'No Action Required' personally. The adhesion process was fixed before packaging any additional materials, as the president
Pharmaceutical Technology's monthly "Agent-in-Place" column distills true-life cautionary tales from the secret files of Control, a senior compliance
officer. If you have a story of clueless operators, oblivious management, inopportune lapses of judgment, or Murphy's Law
in action, please send it to Control at AgentinPlace@advanstar. com
We won't use any names, but if we do use your tale of disaster, courage, or just plain weirdness, Control will send you a
coveted Pharmaceutical Technology t-shirt.