Adjusting to the FDA’s new hybrid Audit and Inspection Model


2020-bl-rca-virtual-audits_715x320It is no surprise that over the course of 2020 with the COVID-19 pandemic that almost all businesses have had to adjust or even completely convert their business models to accommodate more remote work. Whether that be associates working from home, reducing/adjusting personnel flows in a manufacturing plant or just plain implementing social distancing and mask wearing. Everyone has been affected in one way or another. Some organizations already had plans in place for an event like this and others have had to adjust on the fly and the Food and Drug Administration (FDA) is no exception.

FDA recently hinted to a soon-to-be released guidance for industry on remote inspections. This is something to keep watch for in the coming weeks. While I doubt the FDA will ever move to a 100% remote inspectional model, I do think they will try some different strategies to best accomplish their inspectional mission. Also, the FDA started using a hybridized type of inspection approach earlier this year. Simply put, a hybrid approach to inspections (or audits) is using a mixture of virtual tools to help cut down time onsite. Meaning, some time will be spent onsite doing facility walk throughs and testing, while the rest of the time will be offsite doing document review. Also, it’s not just the FDA performing these types of inspections. Others like the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK and the European Medicines Agency (EMA) are performing virtual audits all over Europe. Keep in mind that these regulators are all connected. As collaboration between regulators gets better and better, we’re moving to a sort of “global” regulator. Adjusting to this type of approach can be simple if you are prepared and understand what kind of things will change.

Section 706 of the Food and Drug Administration, Safety and Innovation Act of 2012, gives the FDA authority to "obtain certain records and other information from drug manufacturers in lieu of, or in advance of inspections." This gives the FDA the statutory authority to obtain files such as a list of deviations, list of corrective and preventative actions (CAPAs), list of change controls, complaints since the last FDA inspection, your validation documents, batch records and site master files. This authority covers essentially anything related to GxPs. These are some of the typical things an investigator is going to ask for or could be requested beforehand, depending on the investigator. Some investigators have even come in for the inspection, but if it is a nice day, they might go outside to do a review of documents or interviewing with certain staff and so forth.

With the implementation of the hybrid approach to inspections the FDA is still using a risk-based approach to select companies to inspect, but they have modified it slightly, not only protect the manufacturing site and personal, but to also protect their investigators. In July, the FDA sent out an announcement saying they're using a rating system to assist them in determining where and when it's safest to conduct inspections and call it prioritized domestic inspections. They are assessing the COVID-19 rates in specific areas or regions, or in this case in the United States. Then they decide where is it mission critical to do these inspections, but with the overall caveat that these inspections will be conducted with the goal of protecting the FDA staff and site personnel.

Along with the prioritized domestic inspections the agency also announced that they would pre-announce these prioritized inspections. Historically, domestic drug inspections were basically unannounced, surprise inspections. In this case, they are going to pre-announce them and they've made this change for a couple of different reasons.

  • The site can have personnel available for the inspection.
  • The site is prepared ahead of time so neither the site nor the FDA wastes their time and resources.

The goal is to prioritize critical inspections that the FDA deems important for the public health of the United States over less critical inspections. They may have changed the process for the time being, but it is still risk-based, as it's always been, and the most significant difference in the process is that more risk criteria on criticality and personnel risk is being taken into account.

Preparation

In preparation for a hybrid audit, prepare your documents electronically beforehand. There is going to be a lot of electronic document review within the hybrid approach. So that means preparing ahead of time, and thinking through the entire inspection from an electronic or virtual perspective. Start working on minimizing paper by scanning files so they can be reviewed electronically to ensure multiple people aren't touching the same piece of paper, which is typically done during an onsite inspection. Also, when dealing with electronic files you need to consider how to securely transfer electronic documents. Are you going to use applications like SharePoint or Dropbox or use a regular flash drive?

Other things to think about when preparing for a hybrid inspection, or even an audit, is to consider how you are going to ensure social distancing. From the arrangement of the front room where the investigator is sitting to the conference rooms (aka “back room”) for meetings and document reviews, you should critically think how it will work. Some companies have added plexiglass dividers in their conference tables or just removed chairs, so people are not close to each, thus helping ensure the six-foot distance.

Other things you should think about include the following:

  • What will you use for video portions of the inspection?
  • What does that video look like?
  • How is the internet connectivity around the facility?
  • How strong is the Wi-Fi signal throughout the facility?
  • Do you need to boost the signal to ensure smooth video and sound feeds?
  • Do you need to practice (ex: mock virtual inspection) ahead of time?

Little things like these can mean a lot in an inspection. Critically thinking through the inspection process from start to finish and preparing ahead of time are key.

One key item to focus on is the Wi-Fi signal. If you have dead spots in your facilities, it will interrupt the stream and cause problems. There are certain areas in facilities, like a maintenance/engineering area, that are notoriously loud and have bad signals. Before an inspection takes place, you should do a thorough walk though, check connectivity and install Wi-Fi repeaters in those low connection areas. You should remember that the overall goal in these inspections is to enable the investigator or inspector to go where they want; see what they want, when they want; and how they want it. When you don't have good Wi-Fi connectivity and the video goes out, it not only becomes problematic for the facility, but it could be an annoyance to the investigator or the inspector.

Conclusion

Prior planning precludes poor performance, so prepare ahead of time by thinking 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, see where there are gaps and correct them. The same things go with preparing for a hybrid audit ahead of time. FDA has also stated the it is ultimately the firm's responsibility to assure the quality of their drugs and/or devices. So, it's not a time to slack off and try to cut corners because it can and will catch up to you. Preparing ahead of time for these hybrid inspections will help ensure that your inspection goes seamlessly, but be prepared for the unavoidable bumps, because they are bound to arise when using technology.


Steven Lynn_Headshot 3
Steve has over twenty (20) years of quality and regulatory compliance related experience in the pharmaceutical, biopharmaceutical, medical device, blood, plasma, and tissue industries. He is an expert in Current Good Manufacturing Practices (CGMP) compliance-related matters and has significant experience with other GxP quality compliance and regulatory issues.

Prior to joining Regulatory Compliance Associates® Inc. as Executive Vice President of Pharmaceuticals, Steve served in executive leadership roles with global accountability in both the private sector, as well as at the US FDA. In the private sector, Steve was an executive at two large multi-national corporations and also worked as a consultant for multiple large, mid-sized and small clients. He was the Global Head of Group (Corporate) Compliance and Audit for Novartis AG. In this role he led the corporate-level GxP corporate compliance and audit functions across the company. Next, Steve was the inaugural Vice President of Global Quality Compliance for Mylan, Inc. a large generics manufacturer. Prior to rejoining the private sector, Steve worked for nearly a decade at the FDA. At the FDA, was the Director of the FDA/Center for Drug Evaluation and Research’s (CDER) Office of Manufacturing and Product Quality (OMPQ) within the Office of Compliance (OC). In this role he was responsible for the global Current Good Manufacturing Practices (CGMP) oversight of all drugs manufactured and/or imported into the United States to assure compliance with CGMPs. In addition, in his last year at the FDA he served in a dual position as the Operations Transition Lead for CDER’s new Office of Pharmaceutical Quality (OPQ) reporting to CDER’s Center Director where he was responsible for setting up OPQ operations.

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