Despite FDA’s postponement of most facility inspections, the pharma manufacturing industry should be prepared for heightened scrutiny as this crisis develops. In an unprecedented time amid the global COVID-19 pandemic, an increasing number of pharmaceutical manufacturers and developers of active pharmaceutical ingredients (APIs) are involved in the potentially life-saving development of medications and medical devices. It is more critical than ever that these companies operate under the highest production standards in compliance with Current Good Manufacturing Practice (cGMP) regulations. Despite last month’s Food and Drug Administration (FDA) announcements to postpone most foreign facility inspections1 and all domestic routine surveillance facility inspections,2 the global pharmaceutical manufacturing industry should be prepared for heightened government scrutiny and an onslaught of FDA cGMP inspections as this crisis develops. Click Here For Complete Article Text
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