An Ounce of Rejection - Pharmaceutical Technology

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An Ounce of Rejection
Readers give advice on their best approach to handling (batch) rejection

Pharmaceutical Technology
Volume 33, Issue 1, pp. 16

True Life Cautionary Tales from the Files of "Control," a senior compliance officer

Not so hot

"We had an interesting process step that required a specific time and temperature profile," reports our GMP Agent-in-Place. "To be sure that all parts of the liquid material met this profile, we used several thermocouples and fixed them in place in the process vessel. The production process had not been fine-tuned yet, so the yields were all over the map. Variation of yield exhibited itself at this step as a variation in lot size, which in turn resulted, in some cases, in the upper thermocouples being out of the liquid. When the chart recorder was reviewed, the 'air' thermocouples would not have the correct time and temperature profile, therefore failing the process step specifications and resulting in batch rejection!"

Rejection is better than prevention

"As a junior employee in quality, I was given the job of reviewing label photostats to be sure that the printer was going to print the label correctly including text, colors, and format," says our GMP Agent-In-Place. "It was a time-consuming check, and I would find issues frequently, which would delay the printing of the labels. Sometimes, this would result in a stock-out situation, and the manufacturing and logistics directors would rant and rave about the intolerable delay.

"All of a sudden the label photostats stopped showing up at my desk. So I asked my boss what was going on. Apparently they had convinced the head of quality that my involvement was 'non-value added,' and had written me out of the system. Now the incoming quality assurance staff was responsible for catching the errors, after the labels were printed and delivered. So far, incoming quality hasn't missed anything, and the new process hasn't prevented the delays. Apparently, a material rejection is easier to take than time needed to prevent the rejection in the first place."

Coins and capsules

"We never found out who did it, but someone had put coins in a bulk capsule storage drum," says our GMP Agent-in-Place. "These coins were found during the packaging of the batch, and resulted in a massive investigation, including a 100% inspection of the product packaged so far. We ultimately ended up rejecting all product from that drum."

A stinky joke

"Employees, especially laboratory employees, like to play practical jokes," laughs our GMP Agent-in-Place. "One day, my colleague placed sulfur into a beaker and piped low-pressure air across the top of the beaker toward other lab employees to give them a rotten egg smell. For a while, the other employees kept looking around for the flatulent individual, but there was no one there."

The one that got away (twice)

"One of our senior manufacturing employees was offered an assistant vice-president position with the training group," reports our GMP Agent-in-Place. "But her current manager claimed she was too valuable to let go and tried to prevent the promtion to keep her. The company executive vice-president in human resources stated that no one was allowed to block a promotion and the employee was allowed to take the job in the training department.

"Within six months, the manufacturing department offered her a 'true' vice-president position, which was a promotion above her current position. You guessed it: The training group couldn't block this promotion, and the manufacturing group 'got even.'"

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
. 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.


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