News about GMP/cGMP


FDA: Remote Inspections Will Remain Regular

FDA: Remote Inspections Will Remain Regular

One thing is certain: The FDA’s utilizing remote regulatory assessment is here to stay and remain a regular tool to support onsite inspections. This was addressed by FDA Commissioner Robert Califf and his associate Commissioner for Regulatory Affairs, Judith McMeekin, in a statement released end of July.

With manufacturers and supply chains dispersed around the world, the FDA continually seeks new ways to support a speedy oversight of drug manufacturing.

“As the world continues to move into the digital era, the integration of remote technologies with in-person activity provides a means for the interaction between the FDA and regulated industries to become more efficient so that the agency can have confidence in its assessments and the industry can implement innovations and quality systems in a more rapid and effective manner.”

Along with the statement comes a draft guidance in form of a Q&A document on the expanded use and the conducting of remote regulatory assessments (RRAs). It is stated that RRAs are intended as an additional regulatory tool that does not replace inspections or other established means of obtaining information necessary for the FDA to accomplish its public health mission. Furthermore, it provides specifics on how remote and on-site inspections will supplement each other. RRAs will be useful in seeking to confirm information more quickly and efficiently, particularly when FDA is unable to send in staff due to travel restrictions. Consistency in conducting RRAs is another topic addressed, along with the issue of a risk-based approach when it comes to location, inspection history or product complexity.


FDA: Statement
FDA: Draft guidance on RRAs, Q&A