No more nano
"Our filter supplier informed us that they were going to stop manufacturing the nanofilter we used for one of our products," recalls our GMP Agent-In-Place. "We bought a three-years' supply to be sure we had enough during the change process, which included evaluating alternate filters, validating their extractables with our materials, validating them in the process, performing stability studies, and then gaining FDA approval for the new nanofilter.
"We were lucky and unlucky at the same time," continued our Agent. "The demand for our product went up, but that meant using the filters up faster, so our three-year supply became a two-year supply. We had to parallel track everything to ensure that we didn't run out of product. FDA approval is still pending."Scared of work
"We had a newly pregnant bench chemist," our GMP Agent-In-Place began. "Our laboratory was ordinary and used all the usual solvents, some under hoods for safety. But she was scared of the unknown and what even a low level exposure of solvents could do to her baby. Every day she would add more and more protective gear: gloves, then heavier gloves, apron, then a rubber apron, face mask, then a chemical filtered face mask. It was getting in the way of her performance. We didn't have any other work for her, so we suggested she either perform or take an unpaid leave of absence. She decided to leave."
"We thought it would make a more secure batch record," said our GMP Agent-In-Place. "So we began using a glue-back binding process for the finished records to hold the manufacturing record, the laboratory test sheets, and the inspection data together. It made for a neat data packge. Some records were quite thin, however, and the glue-back binding came in only a couple of thicknesses, so the back was thicker than the stack of papers. These tended not to line up well on the shelf.
"FDA came to the site and asked for a specific batch record. The file clerk couldn't find the batch record," our Agent chuckled (after the fact). "So the supervisor went to look, too. In the end, four people spent nearly a day looking through thousands of records before finally finding the batch record. It had nested inside the folder of another record, and so its back was not visible. Ultimately, it took the tedious removal of every record from the shelves—as well as looking inside each folder for extra pages—before we found the requested one."
All over again
"In 1995, the president of our company asked the head of quality, 'How many people is the right number for quality? How would you know if you have too many?'" remembered our GMP Agent-In-Place. "These types of questions almost always lead to a staff reduction. The head of quality hired a consulting firm to survey several companies to find an answer to the question. The quality department of most companies surveyed represented 10 to 35% of the total manufacturing site personnel. Our numbers fell in the middle of this range. The consultants had surveyed companies making everything from simple over-the-counter products (e.g., antacid tablets) to complex biological injectables. The work being done—and the quality staff needed as a result—makes a big difference. The president of our company thought the enture industry had too many quality department staff. After a review, we lucked out and no jobs were lost.
"Forward to the year 2000, and the president of our joint venture (including the same manufacturing site as noted above) asked, 'How many people is the right number for quality? How would you know if you have too many?'" our Agent related. "This time, the head of quality did his own survey because he wanted to make sure there was an apples-to-apples comparison. For example, some quality departments include validation, some do not. A couple of months later, he provided numbers showing that similar companies had quality departments ranging from 12 to 45% of the total manufacturing site personnel. Again, our organization fell in the middle. It turns out, this was part of a general reorganization and two management levels were lost, as well as half of the packaging inspectors, resulting in 12 quality department staff. The rest of the facility lost the management levels as well.
"This past year, a senior corporate officer asked the same question, and we are once again trying to find a valid answer. Email your suggestions to [email protected]
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 [email protected]