New forensic techniques and approaches are essential for resolving potential safety issues.
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Manufacturers of parenteral products must accept and deal with increasingly strict regulatory expectations for product purity. Quickly and completely identifying a contaminant and its source have become key considerations in dealing with potential product safety and regulatory compliance issues. Failing to adequately characterize a contaminant or failing to identify and remedy the source of contamination can result in costly enforcement activity, including the issuance of a potentially costly FDA Form 483.
Pharmaceutical manufactures have tried (not always with great success) to identify processes and pathways that could help them isolate and characterize particulate contaminants found in parenteral products. Identifying, isolating, and eliminating the source of particulate contamination can be even more troublesome…