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 focusing on the current state of remote inspections and audits.
[Related: To download the full recording of the panel discussion, click here.]
Remote versus Onsite: Lessons Learned
Jason Kerr: What is the most significant change you have been seeing regarding onsite versus remote audits and inspections?
Barbara W. Unger: I think the biggest difference is everybody is learning their way through these in terms of remote audit. There are still many things that you do differently with remote audits, and I’m going to speak to audits rather than health agency inspections, because that is where my experience is. There are so many things that you have to do differently. And so it is a learning curve, both for the auditor and the auditee. But I think over the past year everybody has made progress in that area.
I would say the biggest difference for me is that I am used to dealing with paper when I audit, and I use little yellow sticky notes, and that does not work with electronic documents. So, in many ways I have had to learn an entirely new way of marking up documents because some firms will not let you download…some firms you read them on the screen. Other firms will let you download, but not print. For each company, it is a little bit different for me in terms of how I mark those up and get to the questions that I want to ask.
Stephanie Gaulding: I think my frame of reference is very similar to what Barbara shared in terms of everybody about a year ago started to go through an adaptation to try and move toward being able to conduct remote audits, or in some cases, host virtual inspections or remote inspections by health authorities.
And it really was a learning process. I think in some ways we are still going through some of that learning process. I echo what Barbara said. I am an old-school sticky note kind of person when I am looking at documents in an audit, so I am learning different techniques and being flexible. There has been a new flexibility that I think all auditors need to learn to exercise as you adapt to the way either a CMO or a supplier, or even in some cases, a health authority expects the audit or inspection to actually go.
I would really say that the difference that I have seen is the incorporation and rapid incorporation of those lessons learned into technology decisions. It has grown by leaps and bounds over the last year. I probably would have thought two years ago, you asked me about remote audits and inspections, it is not in our toolkit. It is not the way we do business.
Enter a global pandemic and everything changes. We as an industry have adapted for sure.
Remote Audits and Quality Agreements
Jason Kerr: Since the pandemic has impacted all of us, in regards to remote audits, do you think remote audits would be incorporated into future quality agreements?
Jerry Chapman: I think that one of the big lessons learned in the last 12 to 18 months has been that there are times when a remote audit or inspection or an inspection that is mainly just documents with very little onsite or no onsite visit can really get the job done. It is really risk-based. It depends on the risk of the product, it depends on whether this is the first time the company has been inspected. If you have a company that has a long history of compliance and maybe they are producing something for you that is a fairly low-risk item, then the ability to perform an inspection without physically being onsite is very viable.
And I think what has happened, and has really been forced to happen during the last year or so, is that agencies as well as companies are finding out that, ‘there are times I can use this and it is pretty effective. Other times, not so much.’ I do think going forward that we will see a place for this type of inspection.
Stephanie Gaulding: When I had my interactions with the clients that I work with, one of the first things that came up as we looked at remote audits, and especially from a standpoint of audits of CMOs suppliers, or any kind of service provider, is making sure that not just the quality agreement gets updated to incorporate aspects of remote audit technology, but also looking at confidentiality agreements, whether it is a CDA template or an NDA template in terms of language that’s used in there, and does it really address these types of situations where document sharing is happening.
Admittedly, many of those types of agreements have provisions for handling and sharing electronic information. But I think we want to make sure that they cover everything and look maybe a bit broader around the world as data privacy regulations and things like that creep into play, certainly with the European Union there are GDPR concerns. And from that perspective, making sure that those documents particularly the confidentiality agreements in terms of handling personal data, because if you are not familiar with GDPR requirements in Europe, somebody’s photo and their image is considered personal data. There are certain protections that need to be afforded.
But I think as we move into this kind of age, we will see a natural evolution come out and some new best practices when it comes to language around handling data, remote audits, and allowance for things to be done in a remote capacity or in a physical onsite methodology.
Barbara W. Unger: I agree with Stephanie. In terms of changing the verbiage in quality agreements, I think that can be done easily enough to allow for either remote or onsite. It may be remote one year and onsite the next if you have, say, a good CDMO provider. You use that flexibility then certainly it makes it easier for them I would think for the remote audits, but I think it will be a mix moving forward.
Remote Audit and Remote Inspection Tech
Jason Kerr: What are some of the technologies you have seen used for remote inspections and remote audits?
Jerry Chapman: Following up again from a presentation that I heard just recently from a Health Canada inspector, something that he said really caught my attention, a lot of people are using video conferencing. They are using Microsoft Teams or they’re using Zoom. But I think we have all heard stories about Zoom meetings that have been hacked. Security is important. And this inspector noted that his agency is piloting a video conferencing tool called VidCruiter.
[Editor’s Note: Read Health Canada GMP Inspectors Turning to Video, Teleconferencing; Three Case Studies Presented for more information about VidCruiter.]
And he said he called it a protected B video conferencing option that protects confidential business information. When they set up a remote audit with someone they insist that this technology is used or they will not participate in the audit because they do not believe that the communication is secure. That was a new piece of information I wanted to pass on.
Stephanie Gaulding: From a document perspective, I would say that my preference is really a secure content-sharing repository that can house the documents [I need during a remote audit]. I can actually scroll through them at my leisure, at my pace instead of having to direct somebody through a document, those kinds of things. But when using those I have run into some that are secured to the point where you cannot do things like rotate pages if they uploaded the document. Or it is a landscape page, but it is actually oriented in a portrait fashion.
As an auditor, I really do not want to sit there and do this the entire time. It is a little bit difficult. Think about that usability feature for the person using it. I think about this iteration when I talk about the difference between audits and inspections. When we look at inspections for health authorities, if you are potentially going to use a platform like that, having that discussion with them and making sure that they have the ability to download documents.
[Author’s Note: For more on new technologies for remote audits and inspections, read Part II.]
[Related: The presenters discuss remote audit timeframes in the webinar clip below.]
Will There Be an Inspection Boom Post-Pandemic?
Jason Kerr: Do you think we will experience an audit or inspection boom in the second half of 2021, and also all subsequent quarters because of the backlog of 2020?
Jerry Chapman: It is important to think about what resources are available. If there were unlimited resources, the answer would be different, but each company, each agency has a finite number of resources. So to say, okay, now the pandemic is over and we are going to see this big audit boom, that is not going to happen because the agency does not have the resources to do that. They have a certain number of auditors, inspectors, whoever, and so they are going to obviously do what they can do…they cannot do a surge because they do not have the capacity to do that surge. At least that is the way I look at it.
Barbara W. Unger: I do not think there is going to be a surge in 2021. I think we are slowly going to maybe see more occasional onsite audits. But I think people are still a little tentative about opening up completely, especially when you get into manufacturing areas, because if a large number of people in a manufacturing facility become ill, it has serious consequences to productivity, and maybe to product safety, depending on what it is they make. I think we are going to see things gradually returning to what is going to become a new normal, which I think will be the mix of remote and onsite.
Stephanie Gaulding: I tend to agree with what both Jerry and Barbara said. I am not 100% sure I envision this massive boom that we are all going to see because of exactly what Jerry pointed out. There are resource constraints on all ends of the spectrum. Health authorities have a population of inspectors, right? It’s not that they can magically add a whole bunch more inspectors to accomplish inspections that they may have deferred during the pandemic, etc. But likewise, companies, and even the suppliers and the service providers have a limited amount of [time]. There are 365 days in a year, so there are only so many days of inspection time or audit time that are actually available to us.
And I think the fact that we have proven that we can handle these types of evaluations in a remote capacity in certain situations…I think we will see that blend. I do not know that we will see this rush to return to a lot of onsite activity. Some of the clients and colleagues that I have that do a lot of auditing, whether they are working for companies or as consultants, have actually enjoyed the fact that they have not been getting on a plane going from one city or one state or one country to another country.
This transcript has been lightly edited for clarity.
[Related: To download the full recording of the panel discussion, click here.]
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