Ask the Expert: Proactive Measures to Address Drug Recalls

In this episode of Ask the Expert, published by PharmTech. Susan J. Schniepp and Siegfried Schmitt discuss how companies should approach preventing product recalls.

Link to the Video and Article on Pharmaceutical Technology

Ask the Expert Video Series

In this episode of Ask the Expert, Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, a Nelson Labs Company, and Siegfried Schmitt, PhD, vice president, Technical at Parexel, discussed the recurring problem of product recalls and the proactive measures companies can take to prevent them. Schniepp and Schmitt identify microbial contamination, mislabeling, and physical contaminants like glass particulates as primary drivers of high-level recalls. Despite established quality systems, failures still occur due to systemic vulnerabilities such as reliance on subcontractors, production time constraints, and human error.

Discovery of these issues often occurs “in the field” when patients or doctors report adverse effects to the Adverse Drug Reporting Center. While the FDA usually does not mandate a recall, a company should respond to a high volume of complaints by initiating a voluntary recall to prevent patient harm. Microbial contamination is highlighted as a particularly challenging area because sterility assurance is a matter of probability rather than absolute testing. To combat this, companies should implement a comprehensive contamination control strategy that synthesizes data from environmental monitoring, gown swabs, and water systems.

Schniepp and Schmitt also address the serious risk of product mislabeling, which can lead to patients receiving the wrong dosage or drug. Such errors frequently occur before labeling even begins, such as vials are transported on carts with handwritten, temporary labels that are prone to human error. Because these vials look identical before labeling, a simple human mistake in marking a cart can lead to the wrong product being labeled correctly. To mitigate these risks, the quality unit should not remain isolated but should instead walk the shop floor to identify vulnerabilities that operations teams might overlook due to routine.

Prevention requires more than just possessing standard operating procedures. Companies must regularly test their recall procedures to ensure they can track and retrieve products across complex, global supply chains. Ultimately, the best defense against a recall is a “finely balanced” and well-understood quality system that incorporates International Council for Harmonisation Q10 risk management principles and maintains integrated controls across all manufacturing stages to provide total oversight.