Discussion forum for Pharma Quality events, Regulatory Actions
Warning letters, 483s, Recalls, Import Alerts, Audit observations
Warning letters, 483s, Recalls, Import Alerts, Audit observations
FDA uses Remote Regulatory Assessments (RRAs) to assess compliance of facility with applicable laws and regulations. If a program office determines that an inspection of a facility is not necessary, feasible, or practical, FDA may instead conduct an RRA. RRA is conducted entirely remotely; include a request to conduct voluntary remote interactive evaluations (RIE). FDA believe remote interactive evaluations, based on risk and program needs, will enhance its ability to assess facilities. When FDA determine that facility risks can be assessed and application assessment can be completed without inspection, an RIE is considered. FDA consider the use of a Remote interactive evaluation (RIE) for any of the inspection program areas as below:
FDA determine when to request a facility’s participation in a remote interactive evaluation (RIE). FDA do not intend to accept requests from applicants or facilities for FDA to perform a remote interactive evaluation. FDA will notify a facility of an intended RIE, and request confirmation of its willingness and ability to participate in a RIE. Declining FDA’s request for a remote interactive evaluation could affect timely regulatory decision (such as adequacy of Clinical trial, adequacy of a dossier -ANDA) etc.
One facility confirms RIE, FDA will schedule a virtual meeting to discuss logistics, arrangements, scheduling of the virtual interactions. RIE can include (but not limited to) review of documents, viewing prerecorded videos, remote observation of manufacturing operations or livestream assessment of data. If a facility is unable to support video or other virtual interactions, or if FDA determines that the video or any other virtual interaction during the remote interactive evaluation does not permit a sufficient examination of the facility or of corrective action, FDA may terminate the remote interactive evaluation and instead perform an inspection or use other available tools. FDA will use its own IT platforms – Microsoft Teams / Zoom / Adobe Connect and equipment to host virtual interactions during remote interactive evaluations.
After the RIE, FDA will have a closeout meeting with the facility’s management and present a written list of observations, if any. FDA also shall provide Remote interactive Evaluation report to the facility. FDA will not issue a Form FDA 483 (Inspectional Observations) following RIE. Facilities may respond to FDA during the discussion and provide responses in writing to the observations within 15 U.S. business days.
Also read:
Leave a Comment
You must be logged in to post a comment.