Resuming Normal Drug and Biologics Manufacturing Operations During the COVID-19 Public Health Emergency

On 10 September 2020 the FDA announced the availability of the guidance for industry.

FDA is issuing this guidance to help drug and biological product manufacturers during the COVID-19 public health emergency, plan and prioritize current good manufacturing practice (CGMP) activities as they transition from operations impacted by the public health emergency to normal manufacturing operations. This guidance describes how to evaluate and prioritize the remediation of CGMP activities that were necessarily delayed, reduced, or otherwise modified during the public health emergency in order to maintain production and the drug supply.

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