According to the Pink Sheet, Brian Hasselbalch, in CDER’s Office of Pharmaceutical Quality, stated, at an IPAC-RS roundtable on November 2, 2020, that the FDA was developing guidance on virtual drug GMP audits and inspections using interactive video or other types of interactive tools and techniques. He noted that many companies have volunteered use of these types of technologies. He went on to urge companies to be prepared if they are submitting applications covering facilities that the FDA may want to inspect.
Lachman has conducted many virtual and remote audits, especially in the past few months. We recently launched the use of a fully interactive, remote, live-streaming technology called AvaTour® as a platform to do so. There are many things to consider during a remote or virtual audit and these considerations are not the same as those for an in-person inspection. I recently authored a blog discussing some points to consider. One other consideration that I would add is the need to review and possibly upgrade the available bandwidth in your manufacturing areas in order to ensure a seamless virtual inspection, whether mock by Lachman or real by the FDA.
Now is the time to plan for the future and the FDA’s potential acceptance of this type of technology. Our remote services and a description of the virtual touring can be found here. If you would like us to help you prepare for a remote inspection, contact Linda Evans O’Connor at l.oconnor@staging.lachmanconsultants.flywheelsites.com or call us at (516) 222-6222 today.
