For full functionality of this page it is necessary to enable JavaScript. Here are the instructions how to enable JavaScript in your web browser It’s Official: Active Pharmaceutical Ingredient Makers in FDA’s Crosshairs

It’s Official: Active Pharmaceutical Ingredient Makers in FDA’s Crosshairs

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:

  1. The obfuscation of supply chain information
  2. An increasing number of data integrity question marks
  3. Impurity concerns that have led to recalls

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:

  1. Conduct your own investigations. Do your own due diligence and examine your supply chain closely. Ask these questions: Are you happy with how your suppliers are running their business? Are they following all quality and safety regulations? Do the employ best practices in their production facilities?
  • Conduct a risk assessment. What risks do your suppliers pose to your business? Certainly a quality issue could cause you to recall your products. But if they encounter a long-term issue, what does that do to your ability to manufacture and sell your product? How can you mitigate those risks?
  • Evaluate your suppliers’ supply chains. Understand the full extent of your supply chain. Where applicable, ask where your suppliers get their ingredients? Know who handles you APIs and any other ingredients or components from beginning of the supply chain to the end. We get that its complex, but if you’re the one with your name on the package of the end production, it’s your reputation on the line.
  • Identify alternate sources if possible. It never hurts to know where you might turn in the event that your supplier is no longer available. Product shortages are also a top concern of FDA and Congress, so keep that in mind if you are the market leader for a critical drug.

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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