Glass Quality Crisis Prompts Multi-Faceted Array of Risk-Based Improvements
This article was originally published in The Gold Sheet
Drug makers, glass suppliers and FDA officials who attended a recent Parenteral Drug Association glass quality conference made some progress toward understanding why glass-related recalls have surged and what corrective and preventive measures they should apply.
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Guidance aligns with USP Chapters <790> and <1790>; encourages risk-based approach to identifying and correcting particulate contamination of sterile injectables to build on recent successes in reducing particulate-driven recalls.
FDA reported 1,276 drug recalls last year, the third-highest level ever. Inspections of pharmacies that compounded purportedly aseptic injectables drove the numbers, but pharmaceutical manufacturers also contributed as they struggled with particulates, precipitation and other issues.
FDA and the U.S. Pharmacopeia are looking to improve their standards for drug packaging systems. USP is proposing new test methods for detecting contaminants in plastic packaging systems and has proposed a best practice guide for assessing extractables and leachables, while FDA has announced plans to update its 1999 container closure guidance.