Ask the Expert: Proactive Measures to Address Drug Recalls

Preventing Pharmaceutical Product Recalls

In this episode of Ask the Expert, Susan J. Schniepp of Regulatory Compliance Associates (RCA), a Nelson Labs company, and Siegfried Schmitt of Parexel discuss common causes of pharmaceutical product recalls and strategies for prevention. Key drivers include microbial contamination, mislabeling, and physical contaminants such as glass particulates. Despite established quality systems, vulnerabilities involving subcontractors, production pressures, and human error can still lead to product quality failures.

The experts emphasize the importance of proactive quality oversight and effective investigation procedures. Microbial contamination requires a comprehensive contamination control strategy that integrates environmental monitoring, personnel monitoring, and water system data. Mislabeling risks can arise from seemingly minor process weaknesses, such as temporary handwritten labels and inadequate controls during product handling. Quality teams should actively engage with manufacturing operations to identify and address these vulnerabilities.

Preventing recalls requires more than documented procedures. Manufacturers should regularly test recall processes to ensure products can be traced and retrieved across complex global supply chains. By applying risk-based quality management principles, strengthening controls throughout manufacturing, and maintaining an integrated quality system, companies can improve oversight, reduce the risk of product quality failures, and better protect patient safety.

Watch the video: Preventing Pharmaceutical Product Recalls

Preventing Pharmaceutical Product Recalls