Bob Kelly, Principal Consultant, Lachman Consultant Services, Inc.10.27.23
Earlier this year, the FDA issued a draft Guidance for Industry titled “Alternative Tools: Assessing Drug Manufacturing Facilities Identified in Pending Applications Guidance for Industry” (here). Although the Draft is still out for comments, it gives us a behind-the-scenes look at the FDA’s use of proposed “alternative tools” in conducting remote-based inspections. The proposed Guidance uses a risk-based approach based on product quality or facility-related risks and will be determined on a case-by-case basis by the FDA.
A “Remote Regulatory Assessment,” or RRA, is an examination of the establishment and/or its records, conducted remotely by the FDA to evaluate a firm’s compliance with cGMPs. This includes assessments of application-specific risks or gathering information for a facility evaluation. All records and information sought by the FDA under an RRA would be pursuant to section 704 of the FD&C Act and considered mandatory when requested.
Under an RRA, the Agency may use teleconferences or virtual meetings for clarification of record requests should the facility not sufficiently address the FDA’s initial requests. It should be noted that refusal to provide requested information, or providing insufficient information, can and will result in delays in application actions, issuance of complete response letters, or regulatory/legal consequences (we have seen several recent examples of FDA warning letters citing firms when they have refused to supply requested records). Also of note, establishments cannot request the use of RRAs in lieu of onsite inspections; they are solely at the discretion of the FDA.
A Remote Interaction Evaluation (RIE) is another tool that can be used in conducting RRAs. RIEs include the use of live-streaming video of facilities’ operations, use of teleconferences with facilities’ staff, and/or screen sharing. It is important to note that RIEs are being considered voluntary under the proposed Guidance; however, declining to participate could result in a prolonged decision on an application.
The Guidance also highlights the use of “Inspections Conducted by Foreign Regulatory Partners” pursuant to Section 809 of the FD&C Act. In this situation, the FDA must determine whether the foreign authorities can conduct inspections that meet U.S. regulations and requirements Also discussed is the use of virtual interactive inspections with foreign inspection agencies under a “collaborative assessment” when there is mutual interest in a foreign facility and/or drug.
Finally, the Guidance highlights the FDA’s intent to use remote subject matter experts (SMEs) to facilitate timely decisions on applications. The use of SMEs during remote inspections cannot be requested by facilities, although considered as “voluntary participation,” noting that the rewards of participation include increased transparency and facilitation of data collection.
Any observations issued or corrective actions identified using these proposed processes will require responses within fifteen business days for consideration in an application’s assessment; responses submitted after fifteen business days will be considered in a subsequent application assessment cycle.
Stay tuned for issuance of the final Guidance as it is sure to have a profound impact on the conduct of FDA inspections!
Bob Kelly is a Principal Consultant at Lachman Consultant Services, Inc.
A “Remote Regulatory Assessment,” or RRA, is an examination of the establishment and/or its records, conducted remotely by the FDA to evaluate a firm’s compliance with cGMPs. This includes assessments of application-specific risks or gathering information for a facility evaluation. All records and information sought by the FDA under an RRA would be pursuant to section 704 of the FD&C Act and considered mandatory when requested.
Under an RRA, the Agency may use teleconferences or virtual meetings for clarification of record requests should the facility not sufficiently address the FDA’s initial requests. It should be noted that refusal to provide requested information, or providing insufficient information, can and will result in delays in application actions, issuance of complete response letters, or regulatory/legal consequences (we have seen several recent examples of FDA warning letters citing firms when they have refused to supply requested records). Also of note, establishments cannot request the use of RRAs in lieu of onsite inspections; they are solely at the discretion of the FDA.
A Remote Interaction Evaluation (RIE) is another tool that can be used in conducting RRAs. RIEs include the use of live-streaming video of facilities’ operations, use of teleconferences with facilities’ staff, and/or screen sharing. It is important to note that RIEs are being considered voluntary under the proposed Guidance; however, declining to participate could result in a prolonged decision on an application.
The Guidance also highlights the use of “Inspections Conducted by Foreign Regulatory Partners” pursuant to Section 809 of the FD&C Act. In this situation, the FDA must determine whether the foreign authorities can conduct inspections that meet U.S. regulations and requirements Also discussed is the use of virtual interactive inspections with foreign inspection agencies under a “collaborative assessment” when there is mutual interest in a foreign facility and/or drug.
Finally, the Guidance highlights the FDA’s intent to use remote subject matter experts (SMEs) to facilitate timely decisions on applications. The use of SMEs during remote inspections cannot be requested by facilities, although considered as “voluntary participation,” noting that the rewards of participation include increased transparency and facilitation of data collection.
Any observations issued or corrective actions identified using these proposed processes will require responses within fifteen business days for consideration in an application’s assessment; responses submitted after fifteen business days will be considered in a subsequent application assessment cycle.
Stay tuned for issuance of the final Guidance as it is sure to have a profound impact on the conduct of FDA inspections!
Bob Kelly is a Principal Consultant at Lachman Consultant Services, Inc.
