The Fine Print

The proof is in the proof?

"In one situation, when I was a new quality control employee, I rejected the proof copy of the labels that came in because they hadn't included all the changes that were required and specified in the mark-up provided by the regulatory affairs form," reports our Agent-In-Place. "Several others already had reviewed and signed it, including a couple of managers, however, so I was questioned as to how I, an entry-level employee, could reject it.

"After we sat down and reviewed the labels, they also agreed the labels were incorrect and that they had apparently all just glanced at the proof, approved it, and passed it on. At that time (the predigital age), printers would make up a plate and use it to print a proof so that we could verify the label was correct. When the proof was not correct, our purchasing manager contacted the printer for an explanation. It turns out the printers wanted to save us money, so it used the previous version of the label plate and just made changes to it by scraping off the old information and inserting the new.

"I always suspected that our purchasing manager had agreed to this just to save money and that the 'request for an explanation' was a cover-up. The label-change system standard operating procedure was changed specifically to require a new plate for all changes to labels. In any case, no wrong labels were used, which would have resulted in a recall."

New, but for a limited time

"We put the words New Shape on the label when we changed product shapes, hoping to prevent market share erosion by generics. I noticed that the New Shape label was still in use 12 months later," says our Agent-In-Place, "and regulations only allow the New statement for six months.

"When I pointed this out, the packaging department was pissed off! Apparently, the purchasing manager had obtained a big price break for volume orders and had taken advantage of it. They still had a large inventory of many of the labels that included the word New, and they were not happy about destroying $12,000 worth of labels!"

MD or DVM?

"Most of the products we manufactured were for human use," notes our GMP Agent-In-Place. "But we did sell a couple for veterinary use, too. It was the same formulation and dosage form, but had a separate new animal drug application (NADA) approval for veterinary use.

"A new package was developed using the human-drug package as a template. It wasn't until the stability program supervisor looked at some labels on recently manufactured and packaged stability samples that anyone noticed the label was wrong. The label stated that the product 'must be used under the supervision of a licensed physician' instead of 'must be used under the supervision of a licensed veterinarian.'

"Luckily, the supervisor saw this on the first samples of the first batch, and no bottles had yet been distributed, thus preventing a recall."

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.