On May 18, Redica Systems hosted a virtual panel discussion featuring two of our Industry Experts, Senior GMP Quality Expert Jerry Chapman and Senior GMP Expert Barbara W. Unger. Pharmatech Associates, Inc. Executive Director of Regulatory Compliance Stephanie Gaulding was also a featured panelist.

Redica Systems Senior GXP Specialist Jason Kerr moderated the panel.

The following is a select Q&A exploring the technology side of remote audits and virtual GMP inspections. Part I looked at the current state of remote inspections and audits.

[Related: To download the full recording of the panel discussion, click here.]

FDA Guidance on Remote Inspections

Jason Kerr: The FDA recently published an FDA guidance, Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities During the COVID-19 Public Health Emergency for Industry. Any takeaways or insights from this? Are there any other signals that you found from the guidance that gives you pause and think, ‘I wonder what this will mean in the reality of things in the future?’

Stephanie Gaulding: It was reassuring for me because it confirms the experience that I have had working with clients who have undergone virtual inspections in terms of the fact it outlines initial contact and logistics discussion before actually diving into the inspection itself. That mirrored what I had seen in situations where the FDA had done some virtual inspections. It jived with everything that I was expecting, and it was nice to see some of the details around their preferred platform choices.

For instance, Jerry mentioned Health Canada is looking for some very specific video conferencing technology. Having that information upfront enables firms to better prepare for hosting those types of inspections. If they need to invest in a different type of video conferencing technology, they can source that and not have to do it in kind of more of a reactionary mode. But I think specific to the FDA’s document, it was pretty clear to me in terms of what that pattern would be. And I have actually worked with several of my clients to go back and update their internal inspection readiness practices to accommodate for that decision.

Barbara W. Unger: I think the same thing. My clients have not had health authority inspections that have been remote, so I cannot speak to how they went through that and how that worked. But I think there were not a lot of surprises in the guidance. It all seemed very consistent with what they have been saying and writing and presenting all along with their approach. But staying away from the phrase ‘remote audit’ in the FDA guidance, I think is definitely striking.

Live vs. Prerecorded Facility Walkthroughs

Jason Kerr: What are your thoughts on prerecorded walkthroughs of processes? Do you have a preference for one or another? Do you have more questions when you see a prerecorded one with no one there versus a live recording with no one there or a live recording with lots of commotion going on? Any thoughts and insights on that?

Stephanie Gaulding: As an auditor, I have to say that there is always a level of question in my head when I look at prerecorded videos of whether it’s operations, facility tours, etc. Are they really showing me everything? I cannot necessarily direct somebody, ‘can you turn around to the left a little bit so I can see what is over there?’ which the live video feed provides. But certainly, if you do encounter a prerecorded video technology of operations, et cetera, there are still a lot of questions that you could answer.

Early in the pandemic I actually had an onsite audit scheduled, and literally, it got canceled two weeks before I was supposed to get on a plane to travel. They rapidly circled back with an opportunity to try and find a way to do that in a remote capacity. And one of the ways the contract manufacturing organization chose to handle it was to do a recorded video tour. But as I was going through the documents, I realized that the video did not include certain areas of their facility, like the warehouse. First, I requested that they update their tour video. But I just asked, ‘can either somebody take a cell phone on a video call with me there so we can see it? Or can you get some still pictures or something so that I can see what that area looks like and how you segregate materials and some of those types of pieces?’

Barbara W. Unger: I am not a fan of prerecorded. It gives you a good idea of what the facility looks like and maybe what the flaws are, but that is about the extent of it. I think it is a balancing act depending on how many people you have in the area. You can have background noise. You can have equipment noise. That makes it very difficult for the person who is conducting the tour to be able to speak over the noise so you can actually hear. Seeing a small number of people is a good thing; that is comforting for me. But I think you do not want too many people there because you will have too much activity.

Jerry Chapman: On our website, there is an article that we published on what I think was the best practice that I have heard of. And it’s a mixture of both. This was from Thermo Fisher Scientific. What they did was they did a combination of both. They used this Matterport 3D technology, which is commonly used by realtors.

If you are going to look to buy a house, you can take a video tour through the house. Walkthrough the house. That is what they did. That’s prerecorded. And what it does is it orients the inspector before they get there to the facility so they can see what is where and how it is all set up. Then, once they get there live, then they actually have a 360° camera mounted on an IV pole with wheels that they can wheel through. And they use Microsoft HoloLens and a software called Avatour. And they got really high marks from an EMA inspector who went through one of these at their site. He could say, ‘okay, zoom in on that. I want to see that. There’s a logbook open there, zoom in on that. I want to see what that looks like. I want to see if it is dated properly.’ And they were able to do that.

Validation of Electronic Signatures

Jason Kerr: With the increased use of electronic signatures, what is the extent of validation you expect to see at the user sites?

Barbara W. Unger: I think remote versus onsite e-signatures, same requirements, same expectations. Just because somebody is signing from their home office, as opposed to their desk in the facility, I would not expect any different.

Stephanie Gaulding: For many companies, I think they kind of fell into one or two categories, pre-pandemic. Those that already had robust e-signature processes and tools in place to begin with, and could be embedded in a platform, or it could be a separate signing tool, like an Adobe Sign or a DocuSign, or any other number of tools that are out there that they have tested and validated appropriately for those purposes.

We certainly saw a number of organizations, or at least I did, that were maybe completely paper-based that started to adopt e-signatures, but I would agree I do not think the validation expectation changes with deploying an e-signature tool, just because of the situation that we have been through. It would be the same.

[Author’s Note: To learn what these experts had to say about document sharing and remote inspections, read Part III].

[Related: To download the full recording of the panel discussion, click here.]