What You Need to Know
FDA’s use of Remote Regulatory Assessments (RRA), originally developed during the COVID-19 health emergency, is being expanded. Announced in a Draft Guidance for Industry on July 22, 2022, FDA intends to use mandatory and voluntary RRAs as part of a risk-based approach when in-person Agency staff are unable to be deployed.
RRAs help the Agency to monitor regulatory compliance status of industries in their purview, inform decision making such as product approvals, and allows the Agency to verify information submitted. The Draft Guidance, “Conducting Remote Regulatory Assessments Questions and Answers.,” reminds industry that though RRAs are not intended to be a substitute for inspections, preparations for them should be treated similarly as RRA results could prompt FDA to initiate an in-person inspection.
What Does This Mean for You?
Staying vigilant with Good Manufacturing Practices (GMPs) and detailed record keeping, including Standard Operating Procedures (SOPs), batch record validations and verifications, employee training etc is essential. During an RRA, FDA will request and review records (including electronic), documents, and other information. These will be reviewed and discussed via virtual meetings between FDA and responsible establishment personnel. FDA may also conduct livestream examinations of facilities, operations, data and information.
EAS Consulting Group assists with preparations for an RRA as well as an in-person FDA inspection. Our assessments, mirroring an actual FDA experience, are conducted by expert consultants, former FDA investigators, compliance offers and regulatory experts all of whom have decades of field experience.
Posted in FDA Update.