News about GMP/cGMP


FDA: Q&A for the manufacture of drugs and biological products, their supply chain and inspections during COVID-19

On August 19, 2020, the US FDA issued a 12-page guideline for the pharmaceutical industry in the form of a Q&A, which deals specifically with questions regarding  

  • Manufacturing  
  • Requirements for the supply chain  
  • Inspections  
  • Pending applications for approval and  
  • Changes in manufacturing facilities for already approved medicinal products  

during COVID-19. 

The scope of the Q&As also extends to biological products.

Frequently asked questions to the FDA are addressed, e.g. regarding limited inspection activities or what is meant by the term "mission-critical" in this context. Furthermore, it is clarified how manufacturing interruptions or gaps in the supply chain can be avoided and which data should be submitted where. In the context of applications for marketing authorization, the issues addressed include travel restrictions if a manufacturing facility is located abroad or even has to start production at a different site.  

The guideline is effective immediately and for the duration of the COVID-19 pandemic, as stated by the Secretary of Health and Human Services (HHS). There is the possibility to submit public comments on an ongoing basis. The guideline is to be understood as a dynamic document that is to be expanded or modified depending on the progress of COVID-19.

Manufacturing, Supply Chain, and Drug and Biological Product Inspections During COVID-19 Public Health Emergency Questions and Answers Guidance for Industry