
FDA Gives Guidance on Manufacturing During COVID-19
The temporary guidance discusses the resumption of normal manufacturing during the COVID-19 pandemic.
On September 11, 2020, FDA published
During the pandemic, manufacturing operations may have been impacted by employee illness, travel restrictions, plant closures, and disruptions to the supply chain. The guidance provides detailed information for addressing CGMP deviations, developing a plan to resume normal manufacturing activities, and prioritizing activities. The document includes a list of examples where remediation may be necessary.
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