Following the May 18 virtual panel discussion, “Remote Audits,” the panelists—Redica Systems Senior GMP Quality Expert Jerry Chapman, Senior GMP Expert Barbara W. Unger, and Pharmatech Associates, Inc. Executive Director of Regulatory Compliance Stephanie Gaulding—answered questions submitted during and after the webinar.
The panel discussion was covered earlier in Parts I, II, III, and IV.
Below is a transcript lightly edited for clarity. Also, links to resources recommended by the panelists are included.
[Related: To access the full recording of the panel discussion, click here.]
Q. Are there cases where remote is NOT the recommended method?
Jerry Chapman: From both an industry and agency perspective, there are situations in which a physical presence from the agency/company performing the audit/inspection is critical to performing the assessment. For example, at a site that has not yet been visited in person and has no compliance history, or one where serious issues or whistleblower accusations have been made.
Barbara W. Unger: I would be reluctant to perform a remote for-cause audit for a serious quality problem. But it would depend on the exact nature of the issue.
Q. How many people should join/participate in this remote audit from the customer (auditee) side?
Jerry Chapman: One of the advantages of a remote audit is that subject matter experts (SMEs) can be available when needed for questions by the auditor but do not have to be on site. All key personnel and SMEs should be available to participate but should be in listen-only mode and not on camera unless their expertise is specifically sought.
Barbara W. Unger: I would leave that up to the auditee. Staff who can quickly and definitively answer questions should be readily available.
Stephanie Gaulding: Certainly it is the auditee’s call as to how many participate. Just like an onsite audit, and as Jerry highlighted, it is important to have SMEs available during a remote to answer questions.
Remote Audits and the Lab
Q. Do you have recommendations for effective inspections and audits on laboratory processes?
Jerry Chapman: Inspections and audits of labs are best done by individuals who have laboratory backgrounds and experience. In general, they are conducted using a similar format to a manufacturing inspection in which the processes are observed and followed, documentation is examined, discrepancies such as deviations and out-of-specification (OOS) reports are examined, personnel are interviewed, etc.
Lab environments tend to be especially prone to data integrity issues, so examining audit trails on chromatography data systems, potential password sharing, who has administrator access, etc., are important to review.
Barbara W. Unger: Both PDA and Rx-360 and other trade groups, have published guidance on conducting remote audits. I recommend reading through those.
Stephanie Gaulding: This is one of those areas where it depends on the technology available at the auditee as to how effective a remote audit or inspection of laboratory operations would be. The documents Barbara mentioned provide great advice on conduct and considerations in remote audits.
One of the best things I can recommend for an auditee is to plan out the approach and test it before you are in a remote audit or inspection situation especially if planning to use live feeds of some form.
Q. Since FDA and EU regulators are applying remote assessments/inspections, what are their current learnings? And what will authorities be looking for regarding remote audits?
Jerry Chapman: Both agencies have reported that remote audits have their place as part of the set of tools that are used to assess compliance. Ricki Chase, former FDA investigator and Director, Investigations Branch in the Chicago FDA office, provided a perspective on preparing for and hosting a remote inspection.
Here is an interesting perspective from the Russian State Institute of Drugs & Good Practices (SID&GP) on remote inspections.
Barbara W. Unger: I think both FDA and MHRA have presented their experience and expectations for remote audits. The potentially disconcerting part of the FDA’s approach to remote document review is that it can seemingly go on “forever.”
Stephanie Gaulding: I have seen speakers from the FDA, MHRA, Russian SID&GP, Ireland’s HPRA, and PIC/S discuss their experiences with remote audits (Jerry has covered some in his Conference Spotlight articles). I think highlighting some of those sources is better than us giving the impression that we are speaking for them. Also, I might reference FDA’s recent guidance on remote evaluations as well as the draft paper from EMA.
How to Train for Remote Audits
Q. How would you train a new auditor or someone who has not conducted an audit in a long time to conduct a remote audit?
Jerry Chapman: I think the best way to train a new auditor, or even one who has not been to a particular site or does not have familiarity with technologies and/or processes at a site, is to pair that person with an experienced auditor, shadowing the experienced auditor as an on-the-job-training exercise.
Barbara W. Unger: For someone who has never audited before performing a remote audit might be difficult at best. For an experienced auditor who has not visited the site you can use diagrams, facility layout and people/material/waste flows to help with orientation. You may also use drawings that identify pressure differentials and air classifications.
Stephanie Gaulding: I agree with Barbara. I do not know that I would ask an inexperienced auditor to do a remote audit. The learning curve for auditing skills and practices in combination with lack of familiarity with the site could create a lot of frustration for the auditee and auditor.
As for an experienced auditor, using myself as an example, I have audited several facilities that I have never been to remotely during the last year. In combination with Barbara’s recommendations, I use facility tours to also help orient myself to general facility layout and conditions.
Q. What are the top pitfalls as an auditor? Or auditee?
Jerry Chapman: I think a lack of experience with the remote format and a lack of preparation can cause problems on both sides. I recommend reading the links I shared above to the two Conference Spotlight articles that covered Ricki Chase’s presentation.
Barbara W. Unger: Do not get into the situation where the only way you can review documents is online, with the auditee doing the scrolling. That just doesn’t work. It forces you to switch to a Q&A format.
Stephanie Gaulding: In addition to what Jerry and Barbara provided, I would say for the auditor, not managing the environment I’m in to minimize distractions and interruptions.
Q. How do we ensure remote audits are on the same level or even better than a physical audit?
Jerry Chapman: Remote audits, at best, serve as a watered-down proxy for in-person visits. To get it as close as possible, see how one company used a technology that drew “high marks” from an EMA inspector.
Barbara W. Unger: I do not think it’s possible to ensure that remote audits are “on the same level” as onsite audits. You do the best you can with the limitations and then hope we can soon get back to more routine onsite audits. I do think that for good suppliers/CMOs that a mix of remote and onsite audits will be what we do in the future.
Stephanie Gaulding: I think it is unrealistic to expect remote audits to be the same as physical audits given current technology. I believe there are situations, as Barbara mentioned, where remote audits work well. There are also situations where it is more challenging such as a for-cause audit on a specific issue.
As for initial audits, both in-person and remote audits have their challenges. In many ways, the initial audits are challenged more from the lack of data a CMO or supplier is willing to share (due to confidentiality or proprietary reasons) more than the method used to audit them.
Technology for Remote Audits
Q. How do you get the “true” tour of a facility remotely?
Jerry Chapman: Here is a link to one method that I have characterized as “state of the art.”
Barbara W. Unger: It is difficult to impossible. I do not like prerecorded tours because you cannot take a closer look at anything you might see. I find that tours of the warehouse are the most difficult when done remotely, even if they are conducted “live.”
Stephanie Gaulding: As of right now, the only methodologies I see that come close to simulating an onsite tour are ones like Jerry mentioned.
Q. How do you trust the information provided? Is it possible to conduct a data integrity-driven remote audit?
Jerry Chapman: One way is to have the auditor directly review the auditee’s QMS software—in other words, be connected directly to company computer systems. For example, have someone at the company being audited log into the deviation management system or the change control system and observe as the person who is logged in queries the system and displays records at the auditor’s request.
This is sometimes done during an in-person inspection where the FDA investigator requests output from those systems be displayed on a big screen in real time and requests electronic files in lieu of paper files. In this way, the company has no opportunity to preview the documents prior to them being displayed, which can be challenging and can reveal issues including with data integrity.
Stephanie Gaulding: First, I would say if you are suspicious of something an auditee is providing you (e.g., due to a poor relationship with supplier or poor supplier performance), then a remote audit is likely not a good option. Personally, I go into each audit (remote or in-person) with the same level of default trust. If I detect an issue or suspect alteration, I would discuss it with the auditee or request the onsite audit at a later date.
Second, I think Jerry’s response covers one way you could approach a data integrity audit, assuming data is in an electronic system. Live document reviews can also be done for paper-based systems.
Q. How do you conduct remote audits and maintain the security of the documents shared via software?
Jerry Chapman: Some inspectorates, including Health Canada, require secure tools for document sharing. Health Canada is piloting a video conferencing tool called VidCruiter. It is a protected B video conferencing option that protects confidential business information. Some sites have wanted to use an alternative video conferencing tool. The agency recommendation is to use the protected platform that has been evaluated by the inspectorate.
Stephanie Gaulding: I am not aware of secure sharing platforms that are free to use. Health authorities will have their own requirements around content sharing. For remote audits I’ve done, most auditees have bought a secure content sharing platform for these purposes. There are many options out there at various price points and with a wide variety of features. In some very rare instances, I have received access as part of a remote audit to their eQMS system (e.g., a view-only account).
[Related: To access the full recording of the panel discussion, click here.]
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