WHO Adds Antimicrobial Resistance Fight To Drug GMP Inspection Mission
Soup Of Antimicrobials And Resistant Bacteria Found Near Indian Bulk Drug Plants
Agency calls for manufacturers to control plant effluent in effort to preserve efficacy of antimicrobial drugs.
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Pharmaceutical companies are ratcheting up voluntary efforts to control discharges of antimicrobials from their plants and those of their active pharmaceutical ingredient suppliers so they won’t contribute to antimicrobial resistance. But will it be enough to fend off regulation in countries like India?
Poor inspection history was dropped as a criteria for unannounced inspections, OIG says in an audit report, even as support grows for surprise inspections of poor quality sites. An exhaustive review of foreign for-cause inspections shows the FDA reorganization has sped up a process that must go faster still. Meanwhile, whatever happened to experienced investigators’ training records?
Driven by COVID-19 pandemic challenges, regulatory authorities from multiple regions want to work with sponsors on new joint approaches for expediting manufacturing changes globally and streamlining preapproval and pre-licensing inspections.