• Regulatory NewsRegulatory News

    Expert: FDA’s draft guidance on particle inspections takes different approach than compendial method

    A former US Food and Drug Administration (FDA) official said the agency’s draft guidance on setting up inspection testing programs for detecting visible particles in injectable drugs is meant to address this issue from a good manufacturing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...
  • Regulatory NewsRegulatory News

    FDA addresses establishment of inspection programs for injectables

    The US Food and Drug Administration (FDA) on Thursday issued a draft guidance to help manufacturers set up inspection testing programs to ensure that their injectable drugs are free of visible particles.   The 18-page draft guidance "addresses the development and implementation of a holistic, risk-based approach to visible particulate control that incorporates product development, manufacturing controls, visual inpsection techniques, particulate identification, inves...