Resuming Operations During a Pandemic

ABSTRACT

FDA therefore requests that, "A drug manufacturer whose manufacturing operations have been disrupted by the COVID-19 public health emergency should follow an established plan, which includes returning to normal CGMP operations, with consideration given to when there is a reasonable expectation that normal operations will be maintainable for an extended period of time" [emphasis added by author] (1). FDA requests that in these circumstances drug manufacturers perform the following (1) * Identify these deviations and any necessary remediation actions. * Evaluate these actions as part of their risk management approach. * Prioritize resumption activities based on the results of the evaluation. [...]activities include, for example, critical quality attribute testing, investigations of critical deviations, and evaluation of unapproved changes to critical operations or materials.