RCA Radio is a podcast bringing you the latest news and insights in regulatory, compliance, and quality assurance. A transcript for “Episode 005: Supply Chain Management: Audit Effectiveness and Oversight” follows. Listen to the episode here and on your favorite listening apps, including Apple Podcasts and Spotify.
Erika Porcelli: Hello and welcome to RCA Radio, a podcast covering the latest news and challenges in regulatory compliance and quality assurance facing the life science industries. I’m your host, Erika Porcelli. With the C0VID-19 pandemic affecting countries around the globe, now more than ever, companies are faced with making changes to their day to day operations. In this episode, we will be discussing supply chain management and specifically, audit effectiveness and oversight of service providers. Today I’m joined by Sue Schniepp. Sue is RCA’s distinguished fellow and has been closely monitoring developments as things evolve in the marketplace. Sue, welcome.
Susan Schniepp: Well, thank you Erika. It’s a pleasure to be here.
Erika Porcelli: Well, I’m happy that you could join us today because I know, that you’ve been in a lot of committees and been participating in a lot of discussions around everything that’s going on around COVID. So today, I just wanted to talk about effective audits. And I guess, my first question is really, how can we as companies conduct effective audits during a pandemic?
Susan Schniepp: I think that’s a great question. Because there are a lot of audits that need to be conducted, not only supplier audits but internal audits. And then, due diligence audits. And there’s always, when you’re using or taking use of contract manufacturing organizations or are in fact a contract manufacturing organization, your life is audits. So, I think we have to think a little bit outside of the traditional model for audits. There’s a lot more information that can be done upfront for prep work. So for instance, a review of SOPs could certainly be done externally, to being on site. Questions could be exchanged through email or conversations, teleconferences.
“We have to think a little bit outside of the traditional model for audits. There’s a lot more information that can be done upfront for prep work. So for instance, a review of SOPs could certainly be done externally, to being on site. Questions could be exchanged through email or conversations, teleconferences.”
I also think that, there’s the issue of social distancing and so, to have auditors roaming around the plant could be a challenge for a lot of organizations, contract manufacturing organization, supplier organizations. And so, I think that live streaming or sharing of videos is another way to approach, being able to see something. Now, it’s not ideal. Certainly, seeing something live with your own eyes is much more ideal than having someone walking around with a camera or watching tapes streaming to your computer. But I think it’s the way we have to think now, in terms of COVID 19. We have to be a little bit more outside of the traditional box, so to speak.
I also think that, this requires us to take a look at confidentiality agreements and the disclosure and the type of information we’ll be exchanging with each other, a little more in depth. I don’t think it can be just a strict confidentiality agreement. Yes, I agree to keep information to myself. I think we have to take a look at how tapes or recordings are going to be destroyed or stored after shared with an auditor. So I think, we really need to revamp that whole concept. I also believe, that companies need to up their internal audit game. And really, improve those programs to take on more of the role of, what would an independent auditor review and how would they react. And more serious about tracking responses to internal audit observations.
Erika Porcelli: So, as with all audits, right? Observations come out of those. And I think the real question now becomes, how do we document deviations and conduct investigations, especially in a time where we’re social distancing. Does it make it more challenging? Are there things that people should be concerned about or thinking about as they go through the process?
Susan Schniepp: Well, I think documenting deviations and investigations, we have to follow the procedures. And I think, interviews can still happen. People can still get together and brainstorm, although it may be virtually. It may be using zoom or one of the platforms for sharing teleconferencing. But regardless of what the vehicle is to share and do the investigation, the fact is, investigations still need to take place. And they still need to happen. Now, one of the things that can move it along, I think investigations have to be done in a much more timely manner. And we do need to get to root cause much quicker than we have. These things can’t languish just because… We’ll talk about drug shortages in a little bit. But they can’t languish, because we have to fix them and solve them and move on to maintain our supply of drugs.
I think that one of the things that could help enormously, and I used to work for a company where only quality could open up a deviation in the system, allowing people on the manufacturing line to open up deviations on themselves real time. Or to get out there and say, “Hey, I had this deviation and I know what I did.” Real time is very critical. I think we have to open up the systems and make them a little bit more transparent to everybody in the manufacturing arena, including quality control, quality assurance, manufacturing operations, supplier quality. There has to be a transparency of the system and the ability for people to be able to play multiple roles within that SOP or that investigation procedure. And that’s the only way that we’re going to really get a handle on solving these problems, and ensuring a supply of quality product to patients.
“There has to be a transparency of the system and the ability for people to be able to play multiple roles within that SOP or that investigation procedure.”
Erika Porcelli: Yeah, I think you bring up a good point, especially when you talk about drug shortages. And I think, there’s a number of, we could spend a whole podcast just talking about that, but when you look at the supply chain, what can companies do about auditing their suppliers and maintaining their supply chain?
Susan Schniepp: Well, I think that there has to be communication at all levels. Suppliers have to communicate with their clients. The clients have to communicate with their suppliers. This is a great time to be pulling out your quality risk management plan and making changes to it, revamping it, redoing it to consider these extraordinary times. Especially, when you’re dealing with supplies or materials that may be coming from overseas. Every country is going to open up a little bit differently. Every country is going to have exportation requirements, probably stricter. Making it a little bit harder to get the material into the United States, well, into anywhere, France, Italy. If you’re dealing with country borders, there’s going to be an increased scrutiny on these materials.
So, I think that the sooner people talk to their suppliers and the suppliers talk to their clients. And again, it has to be that transparent conversation. And production schedules need to be adjusted. And supplies need to be closely monitored, and in order for this to work and continue manufacturing safe and effective drugs. Across, around the world, this isn’t just something about getting materials into the US, it’s about getting materials anywhere you have manufacturing going on.
Erika Porcelli: Yeah. So, you look at the supply chain worldwide and we all know that there’re border closures and things of that nature. Would you anticipate or have you heard any feedback from companies that are trying to perform virtual audits of suppliers in other countries? Or is this something that’s still being worked through, as we work through some of the technology challenges that we’re faced with as well?
Susan Schniepp: I think people are still working through the issues, although I know that they are trying. Audits and looking at material and approvals are all continuing to go on. They don’t stop. It’s a little bit slower, because as you said, the technology challenges are there. What concerns me though is, even if we, ramping up the manufacturing capacity of our country to be able to produce materials, we do very little active pharmaceutical ingredient manufacturing in the US. Most of those are coming from overseas. So I think, to gear back facilities to be able to manufacture active pharmaceutical ingredients here. And I’m sure, every country is looking at this issue too. I want to stress it, it’s not just a US issue, it’s everywhere. We have to begin to help people. One, update their facilities, if needed, to make sure that they’re capable. Somehow figure out, what the validation requirements are, again, and whether they’re current and how we can make them current. And we have to do it expeditiously.
“We do very little active pharmaceutical ingredient manufacturing in the US. Most of those are coming from overseas. So I think, to gear back facilities to be able to manufacture active pharmaceutical ingredients here.”
So, that’s a lot of challenge ahead of us. But I’m sure that between clients, suppliers and producers of pharmaceuticals that there is a way to do it. We just have to be clever and think outside of our traditional model. Because the traditional model is not going to carry us through this. In particularly, it’s expected to be around for two years, so we have to figure it out now, so that people don’t run out of drugs. And we face serious drug shortages, if we cannot figure out how to do that here.
Erika Porcelli: Yeah. Yeah. I think the drug shortages is something that we’re hearing more about. I think on a daily basis, at least in the things that I’m seeing. Do you think, given everything that’s going on right now, this virtual auditing and audit effectiveness, should companies be planning for this to be a long term solution based on what you’re seeing in the industry?
Susan Schniepp: I think, for some types of audits and some type of relationships between clients and suppliers, it could be a long term solution. Yes. I think, well established relationships and well established supply chains, where there is a transparent communication between the parties, this could become a new normal. I don’t know that it replaces in face visits for pre-approval inspections or new products. I’m not sure how that would work. But I think, we have to think about it as being a potential long term solution. I don’t know that anybody’s comfortable with having, cutting out eye contact and onsite visit. But it is the way we need to think as we move forward, just for the safety of people. And until we get a handle on how this virus behaves and we have effective medications to treat it and the vaccines to immune ourselves against it, I think that this is some direction we have to explore quickly. And come up with the ground rules quickly, so that we can again sustain the supply chain.
well established relationships and well established supply chains, where there is a transparent communication between the parties, this could become a new normal
Erika Porcelli: Yeah, I agree. I agree. And I think my final question is really, what can we do to maintain oversight of service providers?
Susan Schniepp: I think again, we can certainly make sure that their SOPs are reflective of current practices. One of the things that I’m a little bit afraid of, well not afraid of, I anticipated as being a potential problem is, this is a rapidly moving target. And people are gearing up to manufacture things, maybe they haven’t manufactured in the long time. And so, SOPs have a tendency to lag behind. And we have to make sure that, changes to procedures, changes to validation, changes to manufacturing operations are clearly documented and rationalized in our change control system through the SOP. I think that will be a challenge. Because sometimes, change control can be one of those systems that it can be onerous to a company. It’s hard to get changes through. And there’s a lot of justification. But I think that, we need to make sure that our change control systems are able to handle the rapid changes that might be made.
So for instance, you may have a requirement on the manufacturing line, that a particular step in production be observed by real time by another person. So right there, onsite verification. Well, if you are implementing social distancing in your company and on the production line, then that would be very difficult, for someone to be six feet away and observing real time, a step in a procedure. So, would you have that video recorded and the person would review it over a stream live streaming in a conference room or from their computer at home? I don’t know. But if that’s a change that has to be made, it needs to be done quickly and rapidly. So, we have documented all of these modifications that we’ve made to our original manufacturing processing guidelines. And I think it’s critical now, that quality takes a look at the efficiency of their change console system. And make the appropriate changes, to ensure that it can keep up with the rapid changes that I predict will need to be made, in order to manufacture products.
“it’s critical now, that quality takes a look at the efficiency of their change console system. And make the appropriate changes, to ensure that it can keep up with the rapid changes that I predict will need to be made.”
Erika Porcelli: Yeah. It’ll be interesting to see how things evolve over the next few months in this space for sure. So, I’d really like to thank you for taking the time to provide us with your insight. As always, I’m sure we will have you back soon, as we talk through drug shortages and things that you’re hearing about in the marketplace.
Susan Schniepp: Oh, thanks Erika. And I just want to wrap up. A lot of organization, trade organizations and even for profit organizations, are offering free webcasts to keep the industry appraised of the situation and advancements, and new announcements. And I encourage our listeners to find what those are, who’s offering them and listen to them. Because there’s a lot of good information that can be gleaned from that, those podcasts, webcasts and conferences.
Erika Porcelli: Thank you Sue. As always, appreciate that. And thank you to our listeners for tuning into this episode of RCA Radio. Be sure to subscribe to be the first to know, when we upload the next episode in our series covering supply chain management. Thank you everybody and have a great day.