RCA Radio is a podcast bringing you the latest news and insights in regulatory, compliance, and quality assurance. A transcript for “Episode 009: Virtual Audits and Inspections” follows. Listen to the episode here and on your favorite listening apps, including Apple Podcasts and Spotify.
Hello, and welcome to RCA radio, a podcast covering the latest news and challenges in regulatory compliance and quality assurance facing the life science industries. I’m your host, Brandon Miller. Today we are covering virtual audits and inspections.
Companies in almost every industry across the world have had to adjust due to the pandemic by moving key face-to-face activities into a virtual platform. In this episode, we’ll be discussing virtual audits and inspections, how the FDA is performing these audits and inspections, as well as how companies can prepare for this type of remote work. Today, I’m joined by Steve Lynn, who is RCAs newly appointed Executive Vice President of pharmaceuticals, and he used to work for the FDA. Steve, welcome.
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Hi, Brandon. Nice to be here.
Nice to have you here. Thank you for joining me. I know you’re taking time out of your busy schedule, so we’ll jump right into it. Now that the pandemic has forced most people to work from home for about seven months now, more and more things have been moved into a virtual format. With that being said, what exactly are virtual audits and inspections and why should people be aware of them?
Sure. I mean, bottom line, virtual audits or inspections are exactly how it sounds like. They’re work done virtually. So they’re not onsite. They’re done either via computer, video, video’s conferencing or remote reviewing through some kind of electronic means like an electronic shared E room or, SharePoint or something like that. Why should people be aware of them and know about them is because various health authorities around the world, specific to this conversation the FDA, is starting to use them more and more and more.
FDA is definitely, they’re not saying they’re using this as a replacement for an inspection, but they are using their statutory authority which was granted under section 706 of the Food Drug Administration, Safety and Innovation Act of 2012, which gives them the ability to, and I quote, “obtain certain records and other information from drug manufacturers in lieu of, or in advance of inspections.” Do they have the statutory authority to do it? But I think at this point, they’re not saying they’re going to completely replace onsite inspections with virtual ones. So that’s why companies should definitely be prepared for it, understand it, and be prepared to live through it when it happens.
“under section 706 of the Food Drug Administration, Safety and Innovation Act of 2012, which gives them the ability to, and I quote, “obtain certain records and other information from drug manufacturers in lieu of, or in advance of inspections.”
It sounds like the FDA has been prepared for situations like this that we’re going through today. And with that being said, how will they select companies they perform inspections on, especially now during the pandemic?
Yeah. Good question. So with that, FDA is still doing risk-based site selection for their inspections, but it’s taken on a different flavor with the pandemic. Specifically to not only protecting the manufacturing site and the personnel at the site, but first and foremost, from the FDA protecting their own investigators. So in July they sent out an announcement saying they’re using a rating system, that’s assisting them in determining where and when it’s safest to conduct and they call it a prioritized domestic inspection. So what they’re looking at is the COVID rates in that specific area of, in this case in the United States. So where the rate’s high and they’re using CDC data and so forth. And then they decide, where is it mission critical to do these inspections and with the overall caveat that these inspections will be done to protect the FDA staff and also the site personnel.
The big thing about all this with FDA is they also said they would pre-announce these prioritized inspections. So historically, in the United States, domestic drug inspections are basically surprise inspections. In this case, they switched it around and say they’re going to pre-announce it. And they’ve done that for a couple of different reasons. Number one, it’s so the site can have personnel available for the inspection. The site is prepared ahead of time so neither the site or the FDA wastes their time. Because if you’re getting an inspection now, it’s one of these as I said before, prioritize mission critical inspection. So it’s important for the public health of the United States as deemed by the FDA, and it is important for the site to have the inspection. So that’s how they’re selecting, but it’s risk-based completely right now, as it’s always been. And then, turning it into a public health priority.
“historically, in the United States, domestic drug inspections are basically surprise inspections. In this case, they switched it around and say they’re going to pre-announce it”
And then there’s various reasons for doing that. Whether it’d be something for COVID, a COVID drug, like a preapproval for one of the vaccines or so forth, or something else where they’ve seen or heard some kind of data or indication that there’s a problem with a manufacturing site or so forth, that they need to go and do an inspection. An example would be some kind of complaint, some kind of adverse event that might happen where they feel it is a public health priority to go out and do the inspection. That’s a couple of examples.
So it sounds like they’re kind of sticking to what they’ve been doing, but obviously there’s more preparation in these virtual audits?
Exactly. Yeah. There’s more preparation. And again, they’re taking in basically the COVID kind of rates around the specific areas they want to inspect. Like for instance, in one state if the COVID rates really high, they might not go to that state. They might try to do something else instead of doing an onsite inspection or even a hybrid inspection, which we’ll talk about a little while.
So with that being said, how does the FDA conduct these virtual audits and inspections during the pandemic? And what kind of tools are they using to ensure that these audits and inspections are done properly now that everything’s been kind of moved to virtual format?
I think first and foremost, FDA is not going to conduct a purely virtual inspection I don’t think at this point. They publicly said that virtual will not become the replacement for an onsite inspection. So I think firms should prepare ahead of time to have some type of virtual inspection, but it’s hybridized, meaning, sometime onsite, sometime offsite. For instance, investigator comes onsite to do the facility tour, maybe does some interviews with certain staff, collects documents, and then they do a lot of remote review of documents offsite in a safer environment. I’ve also heard stories where the investigator might come on for the inspection, but if it’s a nice day, some of them have gone outside to do a review of documents or some kind of interviewing and so forth. But firms ahead of time should prepare for some time I would say a hybridized approach. And this is also not the FDA. Other health authorities have publicly said they’re doing these types of approaches as well.
“FDA is not going to conduct a purely virtual inspection I don’t think at this point. They publicly said that virtual will not become the replacement for an onsite inspection.”
Which other health authorities are doing these types of inspections?
One well-known regulatory authority, or health authority that’s doing these is the MHRA in the UK. They were doing a talk publicly recently and there were some trade press where someone quoted some of the MHRA people and FDA people talking about this. MHRA was talking about doing a course risk-based site selection as well, which they have done historically, just like the agency, but also doing these hybridized approach and figuring out the best way to do the inspection. What they need to see on site, how long they need to be on site, and how much they can review offsite. EMA as well I’ve heard has done these in the past on the pre-market side. So where I’ve heard EMA has actually done purely virtual inspections using the Microsoft teams or Zoom and some kind of online shared room, like a SharePoint, like we mentioned before. But also using video cameras to have the facility people walk them through the facility so they can see different things or asking them to look at something and go here, go there, do this, do that kind of thing.
“where I’ve heard EMA has actually done purely virtual inspections using the Microsoft teams or Zoom and some kind of online shared room, like a SharePoint.”
Of course. Yeah. It sounds like that’s kind of the trend with these health authorities is starting to move into these virtual hybrid formats and doing as much as they can remotely.
And I think one point to keep in mind for our listeners is, you remember, these regulators are all connected. More and more and more every day, they’re more connected with each other. So they’re contrasting, comparing best practices. So I think over time, you’re going to see various regulators doing similar things like these hybridized approaches on inspections or using different video capability. Like I said, the EMA where they’ve done a completely remote inspection before on the pre-market side, how can they use that on the post-market side? So I think these things, you’re going to see similar practices, especially along some of the bigger regulators.
“over time, you’re going to see various regulators doing similar things like these hybridized approaches on inspections or using different video capability”
You mentioned best practices, what are some best practices that you have seen or heard of with virtual audits, and or inspections?
So, I mean, some of the best practices that come to mind is, first off a best practices is prepare ahead of time. Knowing that these things, they’re going to pre-announce, but you’re only going to have a finite amount of time to prepare for these type of inspections. So, put in some kind of project management plan in place where this is what we need to do to prepare before they come on site. When they’re onsite, this is how we’re going to do things. How you will even arrange the front room where the investigator is sitting. How do you ensure the social distancing? I’ve heard some companies have had plexiglass on huge conference tables to divide things up or a moving chair so people are for sure not to sit close to each other to ensure that six foot distance that the government continues to talk about.
“put in some kind of project management plan in place where this is what we need to do to prepare before they come on site. When they’re onsite, this is how we’re going to do things. How you will even arrange the front room where the investigator is sitting.”
Also, one thing I can tell you for sure is with the video. So using video in different parts of the facility. So what are you going to use? Are you going to use a phone? In practicing with it, what does that video look like? I mean, I’ve done audits before where people were walking through with an iPhone or a Samsung and the video’s on, but their thumbs over the camera. So little things like that can mean a lot in an inspection. So preparing ahead of time is key. Another big thing, or I would call best practice is checking your wifi capability throughout the facility. So if you’re going to do video, whether it be iPhone or with some kind of thing or an actual camera that has wifi connectivity, making sure your wifi signal is strong throughout the facility because every facility has hot and cold spots.
One area that I’ve ran across that can be quite problematic is in the engineering area where you have your boilers, where you have your water system and so forth. It could be in the basement or somewhere else in the facility that’s not well-connected, there’s not a lot of wifi. I’ve heard firms that have gone through ahead of time during their preparation and actually putting wifi extenders in throughout the facility. When they figure out they have a dead spot, they’ll put one in to ensure it works and they have that ton of connectivity. Because I would say the goal in these inspections is to enable the investigator or inspector to go where they want, see what they want, when they want, how they want it. So when you don’t have good wifi connectivity and the video goes out, it can turn into not only problematic for the facility, but it could be an annoyance to the investigator or the inspector. Whatever health authority’s doing the inspection at the time.
“I would say the goal in these inspections is to enable the investigator or inspector to go where they want, see what they want, when they want, how they want it.”
So you want to make it as seamless as possible. Prior planning is definitely one of those best practices. Preparing walking through the facility with your camera, making sure that you can see the video. And also having, even with an onsite inspection, you have a host for the inspection, same thing with the virtual, you have a host for that. I call it a virtual host that facilitates the inspection. And also first and foremost, just having flexibility because things can be different. They’re definitely different during any of these kind of virtual inspections or hybridized and whatever it may be. And each investigator is different. So they each have their own nuances. They want to see things differently. They might ask for different things. So it’s definitely not always going to be a one size fits approach. So ensuring that you have flexibility with your folks on site.
Yeah. So you’ve talked about the preparation process and kind of the best practices when going through and preparing the facility. Are there any other things you could have in mind that you could recommend to companies when preparing for these audits and inspections? And what are some of the key differences between preparing for virtual audits versus preparing for a face-to-face audit?
I’m going to answer the latter part of the question first. So what’s the difference? So, in an onsite audit, you’re dealing with a lot of paper typically. People typically read faster on paper than they do electronically. So you’re going to be dealing with a lot of paper, making a lot of copies in the back room, stamping the copy and getting it to the front room where the investigator is reviewing it. So there are big differences, I think. There’s going to be a lot of electronic document review. So what that means is, preparing ahead of time, for instance, basically thinking through the entire inspection from an electronic or virtual perspective, even if it is a hybrid type of inspection. FDA mentioned it, a recent trade press article from a conference, they talked about, said to think about, you know, try to minimize paper by scanning files so things can be reviewed electronically so multiple people aren’t touching the same piece of paper, which is typically of course done on an onsite inspection.
“So, in an onsite audit, you’re dealing with a lot of paper typically. People typically read faster on paper than they do electronically. So you’re going to be dealing with a lot of paper, making a lot of copies in the back room, stamping the copy and getting it to the front room where the investigator is reviewing it. So there are big differences, I think. There’s going to be a lot of electronic document review.”
So little things like that, think it through. So think ahead of time. Some of these other things that come to mind immediately, think about the key documents that the investigator inspector, or even if you’re having an auditor coming in. What they’re going to look at and prepare them ahead of time. So some things that immediately come to mind is, list of deviations, list of CAPAs, list of change controls, complaints for a certain period of times, like since the last FDA inspection. There’s typical kind of first things you know the investigator’s going to ask for. The validation master plan from the EU side. The site master file. Things like that.
And also think about other things they might want to see and think about how long it’s going to take to prepare. Because you think about batch records, sometimes batch records, as we all know, can be quite voluminous. So investigator, especially if it’s some kind of pre-approval side or even on the post-market commercial side, they’re going to want to look at batch records. So can you scan these ahead of time and upload them. Same with validation documents. Validation documents can be quite voluminous. So what parts of that you want to scan versus half paper wise? Or can you get it all done ahead of time knowing that if they pre-announce an inspection, it’s only going to be for a finite amount of time. So going back to my original point, project management is key in this and planning it out, how you can do it in a right well, and having a cross-functional team come together at the site to figure out how to do it and how to do it in a seamless as possible fashion.
“So investigator, especially if it’s some kind of pre-approval side or even on the post-market commercial side, they’re going to want to look at batch records. So can you scan these ahead of time and upload them. Same with validation documents.”
And also the other thing that comes to mind, when you talk about a lot of documents going electronic is also what kind of electronic forum can you use to share these documents? Some investigators might want stuff on a memory stick, other ones you could give access to an online shared drive, a secure shared drive. And then ahead of time preparing those documents in that online drive. Even if you prepare yourself and the investigator still wants to put on some kind of memory stick that they supply or something like that, at least having it, thinking it through how to actually separate and kind of organize things instead of having them all over the place, like a batch record documents or batch documents or validations in the same place.
And just how you organize things can save you a significant amount of time, especially during the inspection where the investigator is still going to come in or either onsite or remotely. And you’re going to get those kinds of requests fired at you. “I want XYZ, ABC, and I want it right now.” So having that prepared and thought through ahead of time will save you significant time and alleviate any kind of disruption for the inspection.
“just how you organize things can save you a significant amount of time, especially during the inspection where the investigator is still going to come in or either onsite or remotely. And you’re going to get those kinds of requests fired at you. “I want XYZ, ABC, and I want it right now.” So having that prepared and thought through ahead of time will save you significant time and alleviate any kind of disruption for the inspection.”
Yeah. It sounds like preparation is the key to preparing for any audit. And it’s especially important now with these virtual audits because everything is electronic so you need to make sure you can transfer those documents properly electronically.
So with these virtual audits and inspections, is the FDA and other health authorities still requiring and covering all of the same material or have they had to kind of draw back a little bit compared to doing these audits face to face?
I would say yes. I don’t think the material they’re covering is going away or is being taken away. Put it that way. I think they’re still covering the same materials, but at the same time, remember they’re doing these from a prioritized public health perspective. So they’re going to come in and they’re going to see what they want to see. They’re going to ask for that and I think, coming from a risk-based kind of, they are selecting at risk-based, they’re going to be inspecting risk-based. Each investigator does things a little differently. That’s just the nature of how it works. So I think they’re still going to be looking at the same type of things they’ve looked at in the past, or reviewing it in the same fashion. So I don’t think any of the material that they’ve looked at previously all on-site is going to change from off-site.
“I think they’re still covering the same materials, but at the same time, remember they’re doing these from a prioritized public health perspective. So they’re going to come in and they’re going to see what they want to see.”
That’s why I said in the prior question, think through what they might ask, what format they might ask it for and how you can best prepare it ahead of time to hopefully kind of facilitate the inspection in a more seamless fashion. Also remember that, with these virtual inspections, FDA and other health authorities are using all their tools in their toolbox. So I mean, as they use these tools, as anybody uses a tool, you get more adept at using it. So they’re learning, they’re gaining knowledge in the lessons learned to make things more efficient and effective. So I think with this, they’re going to continue looking for the same documents, maybe in a different format, different fashion, but they’re going to continue looking at the same stuff.
Elaborating on using every tool in your toolbox, it brings me to my last question. Once the pandemic is over and things start to return to normal, do you think the FDA will return to doing all audits and inspections face to face again? Or do you think that they might still continue to perform some hybrid format audits now that they know they’re capable of doing it effectively?
I think the hybridized approach is here to stay. I think some firms might get the hybrid approach, some might get the full onsite inspection. So number one, I don’t think onsite inspections are ever going to go away. I think the amount of material and what you can cover on an onsite inspection is much better and what you can garner from that, reading body language, all the different nuances that goes into an onsite inspection where the FDA is assessing the state of control of that facility. I think you can gain that much more efficiently onsite. Remote, I don’t think is going away. As I said before, as they’re using these remote tools, they’re gaining knowledge. And as they gain knowledge, they learn where to be more efficient and effective.
“I think the hybridized approach is here to stay. I think some firms might get the hybrid approach, some might get the full onsite inspection. So number one, I don’t think onsite inspections are ever going to go away.I think the hybridized approach is here to stay. I think some firms might get the hybrid approach, some might get the full onsite inspection. So number one, I don’t think onsite inspections are ever going to go away.”
So as with the private sector, when efficiencies are found, they want to use them so they can capitalize and spend that money somewhere else more. So they continue to do more inspections or whatever it may be. So I don’t think it’s going away from that perspective, I just think they’re going to continue to learn. And ultimately with the FDA, they’ve had the statutory authority to do this type of activity, remote reviews in lieu of an inspection since 2012. So I think if anything, this unfortunate pandemic has forced the FDA and other regulatory authorities around the world to figure out how to do things a little bit differently. And unfortunately it’s a lot differently now. So I don’t think it’s going away anytime soon, if at all. I think if anything, it will become one of those many tools that the various regulators have in their toolbox to use.
Yeah. Having as many tools in your toolbox as possible is always a great thing to have as an auditor, to make sure that you’re running and making these audits and inspections go as smoothly as possible. And kind of wrapping up here, do you have any final thoughts or comments on anything we’ve covered today?
Sure. So first, thank you for your time Brandon. Final thoughts. Again, prior planning precludes poor performance so prepare ahead of time. Think it through. What could go right? What do you want to go right? What could go wrong and how do you ensure that it doesn’t go wrong? Just like we do in industry, you assess it. Where are your gaps? How do you fill your gaps? How do you mitigate those gaps? Same things go with preparing for these ahead of time. But also, you can take the man out of the FDA, but you can’t take the FDA out of the man. So as FDA has also stated in recent announcements, ultimately it’s the company’s responsibility to assure that the quality of its drugs or devices is there. And basically it’s not a time to slack off and try to cut corners because it can and will catch up to you.
“Again, prior planning precludes poor performance so prepare ahead of time. Think it through. What could go right? What do you want to go right? What could go wrong and how do you ensure that it doesn’t go wrong?”
As you see, there’s still compliance and enforcement actions going on. Not with the FDA, but other regulators around the world. So it it’ll catch up to you. And ultimately what’ll happen is patients will suffer, whether it be unfortunate, adverse events or some kind of drug shortages. I mean, there’s a multitude of things that can happen, but ultimately the brand is going to suffer. Prepairing ahead of time for these types of inspections will help you ensure that number one, your inspection goes seamlessly without a lot of bumps. Prepare ahead of time for bumps because using any kind of remote technology, there’s bound to be bumps. I’ve said before, I think Microsoft needs to have some kind of risk assessment around their Microsoft teams application because sometimes that can glitch. Other online applications like Zoom can glitch so prepare for that ahead of time. It’s bound to happen.
And that’s where I said be flexible. But also again, don’t slack off. Quality is the firm’s responsibility. And I’ll leave you with a quote that I’ve said multiple times. So as the saying goes, the bitterness of poor quality lingers long after the sweetness of low price is forgotten. So going back to that, don’t cut corners, make sure you don’t slack off. You’re making paid products for patients that need these products and they deserve a quality product. And helping getting ready for these types of inspections will make it all the better and make your much more seamless.
“be flexible. But also again, don’t slack off. Quality is the firm’s responsibility. And I’ll leave you with a quote that I’ve said multiple times. So as the saying goes, the bitterness of poor quality lingers long after the sweetness of low price is forgotten.”
Thank you, Steve, for taking the time and providing us with your insight and thank you to our listeners tuning into this episode of RCA radio. Be sure to subscribe to be the first to know when we upload the next episode of RCA radio. Thanks again.