News about GMP/cGMP


FDA: Domestic routine inspections postponed due to Covid-19

The US FDA had already announced on 10 March 2020 that most foreign inspections would be postponed until April with immediate effect. Now domestic routine surveillance inspections will also be scaled back.

However, the FDA will respond to public health emergencies involving FDA-regulated products. Furthermore, domestic for-cause inspection assignments are evaluated and proceed in cases where decisions are mission-critical. During this interim period, other ways to conduct inspectional work will be explored, such as evaluating records instead of on-site inspections. The FDA calls upon the responsibility of manufacturers to produce reliable quality products according to cGMP requirements.


FDA: Coronavirus (COVID-19) Update: FDA Focuses on Safety of Regulated Products While Scaling Back Domestic Inspections