If you follow our monthly cartoon, “Trials of a Medicine Maker” you may be familiar with the character of Pat – a chef who accidentally finds himself in the bioprocessing lab, tasked with monitoring and controlling inherent process variability (read more). We obviously intended this to be a joke, but one US company seems to have taken the idea far too literally.
An FDA warning letter was recently issued to Californian company BioDiagnostics after it was found to be using “kitchen cooking pots and household power tools” to manufacture a drug product in “filthy conditions.” The investigator also found that there was an employee food preparation area within the manufacturing area, “with no separation between open manufacturing equipment, cooking utensils, and personal-use items” – a truly horrifying state of conditions in which to prepare a hemostatic solution intended to stop bleeding following cervical biopsy (1). It seems ridiculous for any pharma manufacturer to be so clueless. In fairness, truly shocking Warning Letters are rare, but there are clearly companies out there who veer widely from standards, reminding us of the importance of regulatory oversight. Whether it’s making sure paperwork and basic testing is up to date or preventing companies from storing everything in the manufacturing lab – even the kitchen sink – regulatory agencies are essential to patient safety. And that brings me to another recent announcement: the EMA has said that it will be further scaling back and suspending a number of its operations as the agency relocates from London to Amsterdam in preparation for Brexit (2). The agency now expects to lose around 30 percent of its staff, but there is still a high level of uncertainty and the figure could be higher. Thankfully, regulatory inspections are not listed as being affected by the EMA’s plans, but with Brexit causing such high levels of staff loss, it could still prove to be a recipe for regulation disaster. The fact that the agency is being forced to suspend any activities at all is a concern – and if the EMA finds itself even more hobbled by the impact of Brexit, who knows what the consequences could be for patient safety?
Roisin McGuigan Deputy Editor
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References
- US FDA, “Warning Letters: BioDiagnostic International 7/12/18” (2018). Available at: http://bit.ly/2AR6lJT. Accessed August 9, 2018. EMA, “Brexit preparedness: EMA to further temporarily scale back and suspend activities” (2018). Available at: http://bit.ly/2nqg28y. Accessed August 9. 2018.
