Just a tip of the cap(per)
"I'm glad I wasn't the forklift driver," exclaims our GMP Agent-in-Place. "Although he wasn't the only one at fault. You see, we had been having problems with sealing the aluminum caps onto the vials after stoppering, and we thought that a new capper would be just the ticket to improve the situation. So a new capper was ordered 'on approval.' That is, we ordered and received it with the provision that it would be paid for if it worked.
"But when we tried to put it to use, it didn't fix our problem, and so this new capper was scheduled to be returned to the vendor. It was staged on the dock, ready for pickup. But someone left the dock door open. During routine shuffling of other pallets on the dock, the capper was bumped hard enough to send it out the door, and four feet to the ground. What was a $50,000, unpaid capper to be returned to the vendor now was an unpaid piece of junk."Management then had to get capital authorization approved to pay for a capper that not only wouldn't work for us, but was accidentally busted."
"Most of us don't give a thought when passing by any of the numerous semi-trucks on the highways. Nor do we consider what they might contain," notes our GMP Agent-in-Place. "We used just such a truck to move product from the manufacturing site to the distribution center that was just one hour away. But one day, our truck became involved in an accident. No one was seriously injured, but inside the trailer the product shifted, damaging some of the glass vials.
"You don't plan for it, but you always need to have a salvage plan for such occasions. All the vials were inspected for damage to the glass and to the labeling, before they were allowed to be sold."
The billion-buck break
"It was the straw that broke the camel's (company's) back," explains our GMP Agent-in-Place. "A pallet of unlabeled, filled glass vials was being moved into storage and needed to be stretch-wrapped first. So the pallet was moved onto the turntable. But the turntable had, over the years, moved from proper installation, which would be flush with the floor, to having the front edge raised about two centimeters above the floor level. The pallet being moved onto the turntable hit that raised edge. Once the pallet hit the edge, many bottles fell to the floor and broke. The product from the broken bottles splashed on other bottles.
"What a mess! The obviously broken bottles were pulled out. The pallet was moved to a nearby room where the bottles were rinsed off using the hose that contained city water. The unbroken bottles were 100% inspected and released. Unfortunately, we later received adverse event reports from this batch, which was traced to contamination from the water in the hose seeping into unseen cracks in the bottles.
"Luckily, no deaths were reported, but the adverse events led to an FDA inspection which, when combined with the (not so good) compliance history of our site, in turn led to a consent decree. A review of several companies' consent decree experience in the literature will show that they can cost a billion bucks!"
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 [email protected]