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    Expert: FDA’s draft guidance on particle inspections takes different approach than compendial method

    A former US Food and Drug Administration (FDA) official said the agency’s draft guidance on setting up inspection testing programs for detecting visible particles in injectable drugs is meant to address this issue from a good manufacturing practices (GMP) standpoint, and not a compendial approach as espoused in the US Pharmacopoeia’s (USP) Chapter 790 method.   Stephen Langille, senior microbiology consultant with ValSource, Inc, and a former microbiologist with the ag...