Since the start of the COVID-19 pandemic, the FDA has had to adjust its approach to in-person inspections. The agency is now taking advantage of the available technologies to maintain high-level regulatory oversight remotely.
In service of this goal, the FDA has developed a new procedure: Remote Interactive Evaluations (RIEs). RIEs supplement planned inspections, support regulatory decisions, and maintain remote oversight of facilities.
While agreeing to the evaluation is voluntary, failing to do so could slow down the regulatory decision-making process. That's why understanding what they are about is integral to achieving manufacturing goals.
In this two-part series, Part 1 will cover the "what, where, and why" of remote interactive evaluations. Part 2 will describe how to prepare your facility for these evaluations.
Important: Remote interactive evaluations aren't the same as inspections or record requests under sections 704 (a) of the FD&C (Federal Food, Drug, and Cosmetic) Act.
What is a Remote Interactive Evaluation?
A remote interactive evaluation is a monitoring process that supplements FDA inspection activity during the COVID-19 pandemic.
According to the FDA, the goal of an RIE is to evaluate medical product facilities to ensure that the regulated medical products are of high quality.
Today, RIEs are conducted only for facilities:
- Where drugs are manufactured, processed, or held.
- Covered by FDA's BIMO (Bioresearch Monitoring) program.
- Registered under section 503B of FD&C Act.
The FDA is limiting on-site inspections to prioritize domestic facility inspections, inspections impacted by travel restrictions, and mission-critical inspections.
But what does it mean to be “mission-critical?”
How Does the FDA Determine What Counts as a "Mission-Critical" Inspection?
Mission-critical inspections are inspections that are necessary for a product which:
- Received therapy or regenerative medicine advanced therapy designation.
- Is used to prevent, diagnose, or treat a serious medical condition for which there is no suitable substitute.
- Requires follow-up because of a recall or due to evidence of serious outbreaks or adverse events (including human and animal food safety issues).
- Is related to the nation's COVID-19 response.
The assessment of whether an inspection is mission-critical is done on a case-by-case basis. During the assessment, FDA uses risk management methods to consider the safety of investigators, the company's employees, and other parties involved.
Your facility may be disqualified from receiving an RIE if:
- It has pre-existing concerns that require an on-site inspection.
- It struggles with data integrity issues.
- It has a poor inspection history.
- It provides information that needs to be evaluated but can't be accessed remotely.
- Technological limitations prevent the FDA's remote inspection of the facility.
- Remote interactions don't allow sufficient examination of the facility.
- Technological limitations don't allow the FDA to evaluate the implementation of corrective actions.
Likely candidates for RIEs include:
- Pre-approval (PAI) and pre-licensed (PLI) inspections — to evaluate marketing applications and ensuring facilities can perform the proposed manufacturing processes in compliance with cGMP requirements.
- Post-approval inspections — to evaluate changes to the drug manufacturing processes.
- Drug quality surveillance inspections — to check overall operations, including quality control and cGMP compliance.
- Follow-Up and compliance inspections — to address drug quality problems or facility-related issues.
- BIMO inspections — to monitor FDA-regulated research under the BIMO program.
To be considered for an RIE, it's imperative to review your organization's IT capabilities.
What Technology Will The FDA Use In Remote Interactive Evaluations?
For security reasons, the FDA uses its own IT platforms and equipment to conduct RIE.
The FDA has proprietary versions of:
- Microsoft Teams
- Zoom for Government
- Adobe Connect
While the FDA is technologically equipped to conduct remote interactive evaluations, it's up to the facility to:
- Arrange a high-quality remote connection.
- Provide high-quality equipment (e.g. cameras and audio)
- Allow access for remotely viewing operations at the facility.
If your facility isn't technologically equipped to support an RIE, the FDA will not perform it. The FDA doesn't supply any equipment or software to enable the evaluation at your facility. It also doesn't use any third-party technologies for security reasons.
How Does the FDA Use Remote Interactive Evaluations?
Unlike with inspections, the FDA doesn't issue a form FDA 483 (Inspection Observations) after the RIE is over. Instead, the agency will just arrange a closeout meeting with the facility's management to discuss observations.
The RIEs can be used to:
- Support the FDA's assessment for pending applications, including making a decision to approve an application.
- Preclude the need for an inspection as a follow-up to a reported concern or defect.
- Support a warning letter, import alert, regulatory meeting as well as recall and enforcement actions.
- Rank or prioritize the facility for a future inspection, especially for surveillance cGMP inspections.
- Warrant a follow-up and compliance inspection or other surveillance actions.
While the FDA stresses that an RIE isn't an inspection, its outcome could:
- Prompt an inspection.
- Change the scope, depth, timing, and sequence of an inspection.
- Uncover information that could become a target for an inspection.
- Become the basis for a warning letter.
No matter how different the FDA wants the RIE to appear from an in-person inspection, it requires just as much or even more preparations. A company would need to go through large volumes of documents and learn how to work with remote communication technologies.
Important: RIE isn't the FDA's final action. However, the agency expects the facility to respond to the observations during the meeting and/or within 15 U.S. business days.
Getting Ready for Remote Interactive Evaluations
Remote interactive evaluations will help the FDA operate within normal timeframes while keeping contact-related health risks to a minimum.
Even though the guidance is only valid during a public health emergency, it's possible that the FDA will continue conducting RIEs after the pandemic. They may also extend to medical devices in the future.
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