In the world of drugmaking, there is little as critical as the safe operations of a manufacturing plant that makes sterile injectable drugs, where potential contamination can prove deadly. Employees must move slowly and deliberately, so as not to disturb airflow. They must wear sterile gowning and cannot move from a less to a more restricted area without regowning, so as not to introduce contaminants. The rules, known as current good manufacturing practices, become more stringent the closer one gets to the sterile core of the plant, where vials of medicine may sit open.
On his first afternoon at Merck’s Durham plant, Menachem’s concern deepened when his FDA supervisor belatedly emailed him a 19-page document, sent to the agency from a confidential informant at the facility. The allegations described a biohazard nightmare. Workers appeared to be defecating and urinating in their uniforms, and feces had been found smeared on the floor of the plant’s production area, the letter alleged. In a sterile manufacturing plant, bathroom breaks can be difficult to take because they require additional time, which could serve as one possible explanation for the events inside the Merck plant. Ungowning can take 15 minutes, regowning can take 15 minutes, and on a night shift, there may be no one else to cover an essential worker during that time, Menachem said.
The informant wrote in the 2018 letter, “How is it that a company that is so heavily regulated due to the criticality of what we manufacture, these VIOLATIONS are allowed to take place year-after-year-after-year.” Until the plant’s managers started firing employees, the letter went on, “this facility will never change.
“Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established and followed.”The COVID Vaccines Are Approaching. Is the FDA Ready to Inspect the Plants Where They’re Made? | Vanity Fair