In October 2023, the FDA issued draft guidance on Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities. The document explains how the FDA operates its remote evaluation program and lays out expectations for the industry.
Although remote evaluations aren’t new, the COVID-19 pandemic greatly accelerated their adoption and industry experts expect them to become even more prominent over the next decade. This transition to remote and hybrid evaluations presents exciting opportunities, but there are also challenges to be aware of. Here, we take a closer look at the draft guidance and highlight some key takeaways:
Takeaway #1 – Only certain operations qualify for remote inspections
Remote evaluations streamline the travel and logistics associated with traditional in-person inspections. However, the FDA notes in its guidance that not every situation qualifies for this type of review. For instance, the document notes that data integrity issues and companies with poor compliance records will still require in-person reviews. Similarly, remote evaluations aren’t appropriate for new facilities and products.
What type of operations might qualify? According to the FDA’s guidance, certain types of drug manufacturing inspections and Bioresearch Monitoring (BIMO) inspections. Even so, the FDA’s draft doesn’t make blanket statements about when remote evaluations will or won’t be used. Therefore, industry experts suspect decisions will be made on a case-by-case basis.
There is one type of inspection that will likely remain in person for the foreseeable future –– the follow-up compliance inspection. These inspections are often triggered by an issue that requires monitoring and therefore presents increased risks. While document and record review might be conducted remotely, the inspection itself requires regulators to visit a facility in person.
Takeaway #2 – All future inspections will be fully remote, fully on-site, or hybrid
Under the new guidance, FDA inspectors will use two factors to make evaluation decisions: the type of inspection needed and the risk involved. When inspection time comes around, companies will receive one of three potential inspection models –– fully remote, fully on-site, or hybrid (a combination of the two).
There’s no way to predict which type of inspection will be used, but the draft guidance lists some basic guidelines. For instance, if documents and records are the focus of the investigation, a remote evaluation makes a lot of sense. Conversely, data integrity issues significantly decrease the likelihood of a remote evaluation and will likely require an in-person investigation.
Companies can accept or refute the FDA’s evaluation suggestions, but many in the industry believe a refusal will lead to significant delays.
Takeaway #3 – Logistics will be key to effectively carrying out remote evaluations
Remote evaluations offer many potential benefits, but as previously mentioned, they can only be carried out in certain situations. In its draft document, the FDA says it will include an assessment of each company’s ability to support remote evaluation through teleconference. Specifically, it will:
- Screen for technological limitations, such as hardware and software configurations
- Check the internet connection, bandwidth, and signal strength
- Identify time zone differences and translational service needs
- Establish methods for sharing information (e.g. formats and software)
After all of these logistics are worked out, a remote evaluation can take place. But, as with anything else involving technology, problems may arise. The FDA has acknowledged this potential in its draft guidance. It defines specific software systems that are FDA-approved and requires companies to use the FDA versions of these programs for security purposes. The FDA promises to give companies as much notice as possible to reduce some of the burden that comes with installing and learning new technology.
Remote Interactive Evaluations – The Bottom Line
We’re nearly three years into a post-pandemic world and one thing is certain –– remote and hybrid inspections are on the rise. Therefore, biopharmaceutical and medtech companies need to adapt and embrace the future. The FDA’s new guidance document establishes a strong foundation and will hopefully lead to greater savings and efficiency moving forward. To read the FDA’s Draft Guidance in full, click here.
At Harbor Clinical, we regularly work with biopharmaceutical companies and medical device manufacturers to establish robust inspection protocols. Our qualified subject matter experts (SMEs) are familiar with the FDA’s new guidelines and can assist you in preparing for a remote, hybrid, or in-person evaluation. To learn more about our capabilities, call (781) 775-0342 or send an email to [email protected].
This article was inspired by a recent guest column in Clinical Leader titled FDA Issues Draft Guidance on Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities.