If there was any doubt whether the entire active pharmaceutical ingredient (API) industry is a target for continued FDA scrutiny, it should be gone.
Donald Ashley, director of FDA’s Office of Compliance, talked about major concerns the agency has with the API industry at the Association for Accessible Medicines’ conference. As reported in an article published by Regulatory Focus, the news arm of the Regulatory Affairs Professionals Society, Ashley called out three specific trends the agency is following:
This is no surprise to us. The moment the investigation into potential N-Nitrosodimethylamine (NDMA) contamination was launched, we started talking about the far-reaching impact it would have. It wasn’t the first time that NDMA was found in an API, and it probably won’t be the last. And it certainly won’t be the only contaminant to enter the supply chain from now until the end of time.
Drugmakers should be prepared for FDA to turn up the heat on API manufacturers. Impurity concerns will certainly have a direct impact on your ability to produce the medications and products your customers and patients rely on, and even lead to recalls. But suspect decisions or bad actions by API manufacturers, even in the absence of a quality assurance issue, are likely to attract inspectors and regulators to your doorstep.
While the agency will move at its own pace in pursuit of its own objectives, there are steps you should be taking:
Once you’ve taken these steps, be sure they inform your ongoing recall planning efforts. What you learn throughout this process may not be written in the words of your “Plan,” but it should frame your thinking when determining how to respond to product quality concerns that have the potential to turn into recalls.
Trust us, the hard work will pay off.
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