Getting life-changing therapies into patients’ hands is a complex process.
Published in Contract Pharma, September 2020
At PCI Pharma Services, we look to provide answers and guide our clients across the drug supply chain ecosystem, anticipating and removing hurdles to ensure the best possible outcome. One of the biggest unexpected hurdles we’ve faced to date is COVID-19. It presented some unique challenges as we, like so many others, had to adjust to doing business in a virtual/digital world because of the new normal.
Yet, the pandemic also gave us an opportunity to be innovative problem solvers, which is what we do best. Beyond urgent issues like getting life-saving medications into countries before their borders closed, the pandemic prompted us to re-examine the ways we work—including the way we conduct our audits. Though all of our sites had the capability to conduct virtual audits and inspections, it wasn’t something we did because there was never a need. Yet, to keep life-saving drug launches on track, we had to start doing virtual site audits for the first time—and discovered an excellent business model in the process.
For our pharmaceutical and biopharmaceutical clients, conducting regulatory inspections and general site audits is standard procedure to ensure that outsourced supply chain providers like PCI are aligned with regulations. These audits allow our clients to gain insight on our processes, review the site metrics, and assess the overall health of the site. But in this unique new COVID environment, both sides had to think creatively about how to handle these processes effectively while following the recommended guidelines and restrictions to ensure safety.
In the past, we hosted onsite regulatory audits, called inspections, as well as client audits. In Europe we have a team of 23 Qualified Persons who understand the entire product life cycle. The procedure before COVID-19 involved the client contacting our Quality department for a specific site and scheduling a suitable time, and describe the purpose and nature of their visit, and we would then prepare an appropriate presentation, discussion and tour as required. Scheduled regulatory inspections work similarly: the regulatory agency contacts our internal regulatory department to schedule a time and the process flows from there.
Because we were already in the process of a digital transformation at PCI, the crisis served as an opportunity to accelerate what we had started. Minimal adjustments were required to modify the audits for the virtual world. Document review was already offered through an online portal, and sites individually assessed the implementation of video footage and photos as lockdown restrictions were put into place. Other clients would ask us to live videotape using a camera or iPad and walk around their particular line, and we would ask them, “do you want to see your product being manufactured?”
The first virtual audit we did was suggested by a regulatory agency that wanted to ensure a timely product launch for a life-saving drug. The site quickly created a standard operating procedure that included a pre-audit planning flow chart and step by step guide for virtual audit planning, as well as a second flow chart of how to handle the virtual audit during the audit. This audit was highly successful; the site then shared their procedure with all our sites internationally, who were very enthusiastic. Shortly thereafter, we began suggesting virtual audits for our global clients. To date, we’ve conducted nearly 50 virtual client audits across all our sites worldwide and 10 virtual regulatory inspections for six different regulatory bodies.
By eliminating the need for travel time, we found that virtual audits have served as a better use of both parties’ time and have allowed for better management of our internal resources. Auditors and inspectors have plenty of time to review documents and can send and ask questions about processes or procedures, as we are readily available. There also is a greater sense of environmental control due to the limited access of people to our manufacturing and packaging areas.
The main limitation of virtual audits is the loss of face time with clients. Meeting the team, having a personal connection, seeing and engaging in the process—these are all helpful parts of building a client relationship that the virtual audit eliminates.
Though we did not face any major challenges, we were able to easily manage any issues that arose with a quick phone or video call. We did find that the adjustment to virtual audits was slightly more difficult for customers that had never been to a PCI site, as they struggled somewhat with visualizing the facility and how their product would be handled, so this has impacted how we have developed our videos and virtual audit platform, to make it easier for them to grasp the overall site footprint.
Preparation is also crucial. You need to understand the scope of the audit, and if you need certain subject matter experts to participate in discussions, schedule this ahead of time to ensure you have the right people in attendance. Make sure the audit host is always available in case any issues or questions arise. And always ask your client for their virtual audit preferences ahead of time, whether paper-based (photos in a slide deck), videotape or live recorded with a camera or iPad and shared in real time via video conference. With all these details handled upfront, things will be much more organized and well-run once you’re on the phone.
While these audits were not more complicated per se for different types of products, it can be slightly more challenging going virtually into some of our specialty packaging or contained manufacturing sites that handle highly toxic products. Despite the windows, the visibility is somewhat limited at these sites and we had to plan around that.
As we adapt to virtual audits, we see them in use for the foreseeable future as a great way to save time, travel and resources. The feedback we’ve received from clients has been overwhelmingly positive, and we see this as an opportunity to leverage newfound efficiencies for our and our clients’ benefit, with in-person audits and inspections potentially shifting to once every other year.
These audits are one of several initiatives designed to incorporate digital transformation as core to our business strategy at PCI. For example, we are launching a new digital platform that will give clients immediate visibility into their clinical and commercial supply chain, and provide instantaneous data and insights to inform decision-making. Created using an agile development process, whereby key clients collaborated and provided input, the platform will deliver transparency to clients and save resources to ultimately help bring life-changing therapies to patients faster.
Like other companies, we have found that some of our old methods and ways of thinking are no longer necessary. And we have proven to ourselves we can adapt to new ways of working, make changes, take risks, and still deliver on the outstanding client experience we are known for in the industry. This success continues to inspire even more out-of-the box thinking from our teams, and can serve as a business model that all outsourcing partners and pharma companies can consider going forward.