US FDA Drafts Guidance Advising Holistic Approach To Further Control Particulates
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.
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The US FDA reports that particulate contamination was the second leading cause of recalls for injectable drugs over a 10-year period. Yet the good news is that the recalls attributed to visible particle contamination has actually gone down. FDA official says it may be premature to celebrate, more work is needed to bring these recalls down and improve the quality of injectable products.
Microbial and particulate contamination drove drug recalls to historic levels for a fifth year in 2014, FDA recall data shows. But the data still falters in identifying the weakest links in global pharmaceutical supply chain quality.
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.