Onsite versus Remote Audits

During the May 18 Redica Systems virtual panel discussion, “Remote Audits,” moderator Jason Kerr asked panelists, Jerry Chapman, Barbara W. Unger, and Stephanie Gaulding about sites requesting delays in remote audits until onsite ones can be conducted. 

Part I covered the present state of remote audits and inspections while Part II looked at new technologies. Part III addressed the challenges of reviewing documents remotely.

[Related: Download the full recording of the panel discussion here.]

Jason Kerr: What justifications can you use to support delaying a remote audit until an onsite audit can be done?

Barbara W. Unger: It would depend on your history with them. Delaying the remote audit until you can be onsite is going to be less acceptable. I think you should delay the onsite and conduct the remote audit. But from a public health perspective, as well as to meet your requirements for, say, a CDMO that is insisting on waiting to do an onsite audit, I think that would be a little tough to justify.

Jerry Chapman: The only way that kind of a justification would make sense that I can think of is, for example, in preapproval mode where FDA or some regulatory agency says, ‘I am not going to approve your drug until I can come onsite. I am not going to do a preapproval based on a remote audit because I have not audited you. I have not inspected you before. You are making a sterile product. There are too many risk factors here. I’m going to delay this audit until I can get there onsite.’ And, in the meantime, your application is held up. And that is a little different scenario than what Barbara is addressing. And I agree with everything she said.

Jason Kerr:  So then just follow up on that, what happens if a health authority conducts the preapproval inspection onsite, and then another health authority conducts a remote inspection since an onsite inspection has already occurred?

Stephanie Gaulding: I do not know whether that’s happened or not. I would envision the scenario where it could happen, in particular, due to the relationship between the FDA and the European Union with mutual recognition. I think the countries where there are some mutual recognition type frameworks already in place, I can certainly conceive of situations where that has probably already come into play. And we just may not even be aware that it has actually happened as part of the process, because that is inherently what those processes are designed to do, which is to share data and information between those health authorities.

Are Remote Audits Here to Stay?

Jason Kerr: What are your closing thoughts?

Jerry Chapman:  I would just like to mention that on the Conference Spotlight section of the Redica website, there have been several articles published regarding remote inspections, such as, how do you prepare for one, how do you host one, as well as the Thermo Fisher article on best practices. These can be good resources.

[Editor’s Note: To read the articles Jerry recommends, click here.]

Barbara W. Unger: I think my advice would be do not ignore these. Remote audits and inspections are here to stay. From an auditor or an auditee perspective, develop some expertise in this area because they are not going to go away.

Stephanie Gaulding: I agree with what Barbara said 100%. These are here to stay, so if you are not doing them and you do not have the infrastructure and capability to handle them, I would start building that infrastructure. There are plenty of resources out there. 

Do not ignore them. They are a part of the toolbox, and, therefore, we just need to make the adaptations. And some of us need to be willing to learn some new auditing styles and techniques to manage through them.

[Editor’s Note: Do not despair! This is not the last of the Q&A from the May webinar. Following the panel, Jason and the panelists reviewed questions they were not able to answer during the webinar in Part V.]

[Related: Download the full recording of the panel discussion here.]