How CDMOs Can Avoid Package Integrity Recalls Through Sustainable Compliance

By Tyler Harris, Application Engineer, PTI

Having the foresight and control to detect problems before they occur protects public health in myriad ways, especially when preventing quality issues that can result in costly recalls. This is more important than ever as innovations in science and technology are leading to exciting discoveries and novel drugs that stand to change millions of lives. The industry must be able to meet the moment by ensuring the integrity of these drug products as well as their container and closure system is maintained at every phase of development and manufacture. This includes preserving their sterility and stability.  Yet, a lack of sterility assurance is the most frequently cited quality issue for drug recalls. Manufacturers facing a recall ― and, if applicable, the CDMO they partnered with ― will need to identify what went wrong and where, all while the affected product(s) is removed from the market and production is suspended until the issue is resolved.

Thus, protecting your customers’ products is critical to their future success as well as your own. You can mitigate the risk of recalls by selecting a container and closure system based on the unique characteristics of a drug product and utilizing advanced CCIT methods that help detect package integrity issues before they threaten the quality and availability of these medications. Download the full article to learn what questions CDMOs should ask customers to identify the right container closure integrity testing method for their product.