The U.S. FDA Will Be Expanding the Use of Remote Regulatory Assessments

During the COVID-19 pandemic, the U.S. Food and Drug Administration (FDA) needed to adapt to health recommendations like facility closures and social distancing while still overseeing the production of food and drug products the public used daily. The solution was Remote Regulatory Assessments (RRAs). In late 2023, the FDA announced it will be continuing its use of RRAs beyond the pandemic and will be expanding their use.

For some companies, this may be a welcome sign. Remote assessments can be less intrusive than physical inspections and be completed more quickly. However, this is largely dependent on the state of digitization at the site or organization. While even physical audits benefit from digital documentation and validation records, like those enabled through Kneat Gx, RRAs are drastically improved by the use of digital records.

What Is an RRA?

These assessments are an entirely remote evaluation of FDA-regulated sites and/or a site’s records to evaluate compliance with applicable regulations. The term RRA is a broader category of examinations, including remote interactive evaluation and remote record reviews. An RRA may be mandatory or voluntary and they do not limit the FDA’s ability to conduct inspections, meaning the FDA may still decide to send an inspector after an RRA is completed.

When Is an RRA Mandatory?

As per the FDA, “Establishments that engage in the manufacture, preparation, propagation, compounding, or processing of a drug are subject to section 704(a)(f) of the FD&C Act.” These in scope companies may be notified of mandatory RRAs for specific sites or records. The FDA may choose to not exercise its right to mandate an RRA and instead request a voluntary RRA from an in-scope company.

Under the Foreign Supplier Verification Program (FSVP), importers of food may also be subject to mandatory RRAs.

Is an RRA an Inspection?

Technically, no, but that doesn’t mean they should be taken lightly. Under FDA regulations, an inspection involves an officer or employee “physically entering establishments” so an RRA is not considered an inspection under section 704 of the FD&C Act. However, remote requests for FSVP records may be used to establish compliance for food exporters.

For domestic drug or medical device manufacturers, a denied or failed RRA will almost certainly result in an audit and increased scrutiny. It’s in the company’s best interest to respond promptly and comply with requests for RRAs.

What Records May be Requested During an RRA?

Many documents may be requested during an RRA, including:

• Records of specific production lots or batches
• Product-specific information such as periodic product reviews
• Product quality reports
• Equipment records
• Process validation records and reports
• Test results
• Other Current Good Manufacturing Practice requirements

How to Prepare for an RRA

Much like an audit, each assessment will vary depending on site, records, organization, and product in question. The best way to be prepared for an RRA is to have digital documentation and records. Paper-based record keeping is prone to error, costly to maintain, and inefficient to execute. An RRA will take longer and require more effort to complete when using paper-based records.

A digital document management system or digital validation solution like Kneat Gx, not only stores and centralizes all relevant documentation, tests, and records, but makes it easier to conduct the tests in the first place. Digital tests can be remotely reviewed and approved, and digital signatures are automatically time stamped for more secure ALCOA+ compliance than paper-based records.

You can learn more about the benefits of Digital Validation in Kneat’s Digital Validation Handbook

The Digital Validation Handbook:Your Guide to Faster, More Accurate Validation

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About the Author

Tristan Worden – Senior Content Marketing Strategist, Kneat

Tristan has over a decade of experience communicating complex ideas to both general and specific audiences with almost five years in the compliance and validation sector. He is passionate about ensuring validation professionals have the information they need to do their jobs effectively.