Rebottled

"The new stability supervisor was using a standard inventory request form to order bottles and caps for repacking bulk tablets into suitably sized stability samples," began our GMP Agent-In-Place. "When he realized he had ordered an excess of some fancy, clear over-the-counter bottles with screw caps, he decided that instead of storing them or throwing them away, he'd take them home. They ended up being used to bottle homegrown and dried herbs for his family Christmas gifts that year."

Noncompliant elevators

Super blank slate

"One employee held several positions within our site, each one more responsible than the last," noted our GMP Agent-In-Place. "This was back before computers and electronic-filing systems became ubiquitous. When it came time to move offices, this person fit all his files in a shoebox—and most of the items were personal, not work-related. I guess he thought everything he needed would be at the new office."

Cutting up at work

"It started as a complaint of foreign debris present in sterile solution found at a customer's location," grumbled our GMP Agent-In-Place. "We examined inspection rejects for two current batches of the same product and found similar debris, so we knew the compliant had validity. Our outside laboratory determined that all three debris samples were identical, and that they were Tyvek. Since the Tyvek also had silicone on it, the source was determined to be the stopper bags. We sterilized our stoppers in Tyvek bags, and cut them open in the sterile suite for use. Apparently, in some cases, the operator cut twice, giving a chance for Tyvek pieces to fall into the stopper hopper, and to be transferred to the solution via the inner surface of the stopper.

"To prevent recurrence, we changed the configuration of the stopper bag to use less Tyvek, making the bag more difficult to cut and prevent the need for double cutting. The operators were retrained but, unfortunately, the bag changes required a sterilization revalidation," our Agent finished.

Gone missing

"For certain biological products, a sterility test has to be performed for the bulk sterile material," our GMP Agent-In-Place explains. "This requires that a sample be taken. On this fateful day, the sterility sample for one batch was missing. The batch record documented that the sample had been taken and signed for, but the sample could not be found. The sterility test could not be completed and the batch was rejected. It was suspected that the samples were waiting for seals to be transferred into the filling area, and were inadvertently discarded."

Environmental error

"I hate computers," complained our GMP Agent-In-Place. "I had to review the validation for changes to our enterprise management system and found that five different scripts were tested in the wrong system environment. We have environments labeled sandbox, development, quality, validation, production, and more. Each one is set up on a separate computer server and uses different software. There was a deviation covering these cases, and the documentation said the cases were rerun in the correct environment, but that was inadequate. For example, the response did not identify how the error was determined nor did it offer assurance that the error was limited to the five listed scripts. In the end, we had to check all the scripts. We realized that our initial training of some contract employees was lax in this regard, and was corrected before the next validation runs."

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 AgentinPlace@advanstar.com
. We won't use any names, but if we do use your experience in the column, you'll receive a Pharmaceutical Technology t-shirt.