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The overall quality of a final drug product depends on the components of its packaging and delivery systems.  The use of visually inspected components reduces the risk of defective components and helps ensure patient safety.

Spotting a quality issue on a stopper or plunger can be difficult. While a trimming or molding defect may be noticeable, embedded particulate or foreign contamination may be far too small for the human eye to see.

Drug shortages put patients at risk. Adverse health consequences can occur quickly when shortages make maintaining and/or complying to a therapeutic regimen difficult. In a recent paper, Center for Drug Evaluation and Research (CDER) director, Janet Woodcock and her CDER colleague Marta Wosinska  offered insight into the challenges CDER faces in choosing a course of compliance action when shortages of critical drugs occur.  In the paper, CDER officials cited quality issues as the largest cause (56 percent) of drug shortages in 2011.

As biologics and other injectable drug products gain market share, greater scrutiny is being paid to the interaction between the drug product and its container closure system, including stability during shelf-life and particulate burden, among other critical quality attributes. Over the last several years, drug product recalls have increased due to quality issues, including fundamental weaknesses in primary glass containers that have resulted in problems such as breakage or delamination. Additionally, as more attention is paid to the integration of primary drug containers with devices to form combination products, finding solutions to these problems has taken on an increased urgency in order to protect patients by assuring the integrity and proper delivery of drug products.