By Amy Scanlin
When the phone rings at EAS Consulting Group lately it is very often someone seeking assistance with Good Manufacturing Practices. While COVID-19 has caused major disruptions to global supply chains and manufacturing capabilities, FDA regulated industries forged ahead, with many considered essential businesses. Though saddled with challenges such as reduced staffing, redesigned plants and/or operating hours to accommodate both social distancing and cleaning requirements, these firms thought outside the box to nimbly and creatively adapt to meeting FDA temporary guidance and overcome limitations to supply chains, particularly those coming from overseas.
In normal times, federal directives would result in consultants rushing to facilities to conduct mock-FDA audits and inspections, and gap analyses helping to ensure companies understood and could comply with FDA’s requirements.
These are not normal times, however, and in these days of travel restrictions, not only by air, but also quarantine restrictions for travel between states and countries, FDA-regulated industries are seeking alternatives such as virtual consulting, whereby those same inspections, audits and GMP assessments are made through a reliance on digital eyes and electronic documents.
“Virtual consulting offers a fantastic opportunity to get “into” a facility to cover gap assessments and CAPA development,” says Bryan J. Coleman, Senior Director of Pharmaceutical and Medical Device Services, of engagements his team has had with clients, particularly those seeking to ramp up or begin OTC sanitizer production. “FDA may have temporarily limited inspections to only the most apparent egregious of offenders, but they maintained oversight vigilance as they developed protocols that provided an effective and safe path forward for both inspectors and the industry.”
“It’s an 80% solution,” says Tara Lin Couch, Ph.D., Senior Director for Dietary Supplement and Tobacco Services at EAS, who along with her colleagues are facilitating virtual inspections and mock-audits through live-stream webcams, scheduled personnel interviews, and thorough and detailed document reviews. That eighty-percent solution lies in the fact that there is no 100% substitute for in-person audits which enable a full 360-tour of a facility. Just by the nature of remote, the ancillary occurrences happening beyond the camera lens may be missed. That’s where a true partnership between client and consultant comes into play to ensure the most comprehensive of services that can be provided is.
“Through virtual consulting, EAS has been able to provide seamless support for our clients,” says Allen Sayler, Senior Director for Food Consulting Services. “We’ve been asked for everything from desk audits of SOPs, detailed assessments of processing systems and equipment, to full FSMA-based compliance virtual audits where we look for written gaps in processes and procedures, places where product safety and quality could be compromised. This is followed by a thorough written report of gaps and recommendations on how to close those gaps as well as follow video conference call to discuss the reports. Using a variety of real-time and recorded video technologies, the consultant is able to ask the client to zoom in on particular points of interest or pan out for more general operational views. Our remote consulting technology also allows the client to share documentation during the remote inspection, enables EAS to verify Good Documentation Practices, just as if EAS or FDA were there in person. In every way, the virtual audit as an extension of our audit services is proving to be very effective.”
“We get a number of requests for dietary supplement Foreign Supplier Verification Program reviews under FSMA,” adds Couch. “COVID-19 has in some ways completely altered the way companies do business and it is important to ensure, even if using a different supplier, that they are vetted, that traceability is intact and that the end product will have the same quality and meet specifications as it did originally. We are pleased that EAS has been able to help so many through that process.”
As part of those remote inspections and audits, in-depth personnel interviews including staff from departments such as operations to quality are utilized, just as they would be in-person, to pull new threads in an attempt to decipher problems not readily evident. That digging for puzzle pieces is all part of the complete picture that FDA will assemble and what EAS audits and inspections, both in-person and virtual, offer as well. Another benefit to a remote audit? Time. The tour can be broken out into multiple shorter days so that the facilitating staff can better focus, dividing time between continuing to run productions and later devoting full attention to the inspection task at hand.
Since FDA has begun to restart its in-person domestic inspections, the preparation for these must remain diligent and thoughtful. There is much to consider when choosing a regulatory partner as you further your food safety and operational compliance. Reputability in the industry, expertise of the consultants with whom you’ll be working, professionalism and experience with businesses such as yours that provide an appreciation for the specific challenges of your industry can all be met by EAS.
Through virtual consulting with EAS, you’ll be assured of valuable and actionable feedback so that your firm can continually strive for improvements. FDA will come knocking one day. Better preparation today will lead to a higher level of confidence in a positive inspection outcome tomorrow.