[0:05] Intro: Welcome to Measuring Up: Thinking Out Loud, featuring news and information from Testo, your consultative resource for precision measurement technology and digital solutions, serving the pharmaceutical, industrial, and allied industries worldwide.

[0:22] Bill White: Hi, this is Bill White for the Testo Information Network. We're on the line today with Amy Shortman, the founder of ASC Associates. Amy's a worldwide presence, but based in Cambridge, England. Amy, good morning. 

[0:39] Amy Shortman: Good morning, Bill. 

[0:22] Bill White: I wanna just do a little background on you. You're a fellow of the Chartered Institute of Logistics and Transport. And a Fellow Chartered Marketer with the Chartered Institute of Marketing (CIM). Amy, what does that mean?

[0:54] Amy Shortman: Well, I suppose they're industry accreditations for the fact that I have been in the industry a long time. So, I have supported the Chartered Institute of Logistics, giving back, working with some of the universities' masters programs, but also undergraduates, developing projects for them. And so that's really part of my role is to give back to the industry, and the fellowship is a recognition of that. As with the Chartered Institute of Marketing, I have been doing product marketing for most of my career, particularly within the last 10 years. So, it's just really saying that I've been around a long time, so therefore I get a fellowship.

[01:34] Bill White: OK, well, you bring 29 years of leadership experience across all facets of the industry. I'm particularly interested in your air freight, and you’re experience as well. Your company was established in 2011 after you saw a need in the industry for some practical experience, training in pharmaceutical logistics, and boy, we learned a lot then.

[01:59] Bill White: And since then, you've supported global pharmaceutical companies in the whole idea of supply chain security and quality auditing. Today, you're working with the Healthcare Distribution Alliance, we'll refer to that later as HDA, and the Pharmaceutical Cargo Security Coalition (PCSC) to raise the standards for pharmaceutical transport. So, we're happy that the industry is evolving and focusing on that safety. Let's talk about the whole concept of good distribution practices. Why was this introduced?

[02:38] Amy Shortman: Oh Bill, this is a drum that I have been banging since the early 2000s. So good distribution practice is really about making sure that medicines remain safe and effective and protected whilst they're being transported. We know, as an industry working closely within the pharmaceutical space, that the amount of money, research, and development that goes into actually manufacturing pharmaceutical products, once they leave that dock door, once they're being transported, they really have to be at the same conditions, the same standards, the same protection as they are when they're actually within the warehouse. So, what good distribution does is it makes sure that everyone who's transporting the goods is taking as good care of them as they were when they were being manufactured in the warehouse. So, for me this is something that I introduced to through the MHRA (Medicines and Healthcare products Regulatory Agency), which is the UK regulatory agency, back in the early 2000s, and it just made common sense. I was like, this is amazing. This is helping our logistics industry understand how we can help the pharmaceutical industry that we want to work with move products in a safe and effective way. 

[03:52] Bill White: Makes sense. What was the industry overlooking before? What were they not doing?

[03:56] Amy Shortman: So, they were just kind of focusing on transporting.

[04:00] Amy Shortman: And back when I started in the late 1990s, it was some companies were thinking about temperature control, but some were just, let's try and use the stability data that we have for products. So, most products, if we think of, you know, we go and collect a medicine from a pharmacy, and there is stability data that says that that product will still be OK if it's left in our car while we're bringing it home, before we may put it in the fridge. So, there is some allowability built into that. And what they were doing back then was saying that, well, we'll just use that bit for transporting it, not thinking about the patient at the end, collecting it from the pharmacy. So back then, I would see companies moving 228 diagnostic kits (FDA 22 CFR Part 228), things that were incredibly important, HIV medicines that were being moved without actually having any temperature control. They were just hoping that the environments it would pass through would keep it in the right conditions. So, we've moved on a huge amount since then, but it's still evolving, still growing, and we're still making sure that now every single person that comes in contact with that product has a level of awareness. They know how it should be treated and looked after while it's in their custody.

[05:16] Bill White: It seems to me that the ambiguity there would have affected the data for clinical trials as well. Do you think that was the case?

[05:25] Amy Shortman: Yeah, so my first job, when I started out all those years ago, was actually working with research and development materials. So, a lot of clinical trials, a lot of compounds were being studied to see what these compounds did and if they had any medicinal benefits for patients. So, some of the companies, the company I worked for was Biocare (Biocare Medical), other ones out there, like World Courier, were shipping a lot of the clinical trials under good conditions, and they were really, and that was my kind of entry to the industry. I was thinking, well, if they can do it, why are the bigger forwarding companies, why are the 3PLs not moving them in this way? Because they took such care and attention to detail. They were temperature monitored back then, even back in the late 90s. They were using temperature-controlled packaging. So, it was really about sort of taking that quality, that sort of standards that those companies had into the more sort of mass market, larger scale. And I think that, you know, it does have an implication on data. It does have an implication on efficacy of medicines. And I think that, you know, we realized as an industry that there is a benefit to us as humanity to have products that are working and data that is reliant. And so, it's only in everyone's best interest.

[06:47] Bill White: We're with Amy Shortman of ASC Associates in Cambridge, England. We'll be back in a moment.

[06:55] Intermission: You're listening to Measuring Up: Thinking Out Loud, news and information from Testo.

[07:05] Bill White: Amy, where do you still see gaps between the written standards and what's actually being done out in the industry?

[07:14] Amy Shortman: So, there is variation globally. I think that's the first thing that we need to consider with GDP (Good Distribution Practice) because of the regulatory framework, we have different Good Distribution Practice guidelines that are adopted in certain areas of the world, so there's not one regulation that everyone is adhering to. Each country's health authority has a responsibility to make sure that their country is manufacturing and shipping goods to a certain standard. So that's really where the decisions upon which standards they're going to adopt. Now, the EU GDP standards for medicinal products for human use tend to be the sort of best in class one that most of the other ones are geared towards. They reference them or they sort of take parts of them into their own standards. Within the US market, we have a combination of different regulations. So, Drug Supply Chain Security Act, we have the FDA Regulations as well. We've got United States Pharmacopeia (USP) and also Good Manufacturing Practices that reference the distribution part of it. So first of all, the landscape is incredibly complicated. So, what we find is that, and historically, if people don't have to do something, they won't do it. 

[08:34] Amy Shortman: So, what was happening perhaps in the US market 10 years ago, between 5 and 10 years ago, was that pharmaceutical companies were aware of it. Transportation companies perhaps not so much, and the pharmaceutical companies were not mandating it as part of their RFQs. So, then the transport companies were saying, well, it sounds like something would be nice to have, but we don't need to have it. That's changed massively. And I think what we find is that there are differences in maturity of an adoption of quality standards within the transport industry. There's also differences in how companies are temperature mapping their vehicles, temperature mapping their warehouses. A lot of companies, this is a very new thing that they're having to do, so things like calibration oversight or perhaps not having the correct standard operation procedures to handle the goods in a way that is compliant. So, you know, policies are really easy to write, but actually making sure that that's operational discipline is done every single time a pharmaceutical company moves something, that's a lot more challenging, so yeah, that's what we find.

[09:44] Bill White: And there have been tremendous strides in that part of the industry, I'm sure you'll agree. You've been working with the Healthcare Distribution Alliance for a long time. What prompted that collaboration?

[09:58] Amy Shortman: Hm, well, first of all, the, you know, the Healthcare Distribution Alliance and the Pharmaceutical Cargo Security Coalition subset of that has been really working in the industry to make sure that cargo, security, and quality standards are a really big part of what should be offered as a benchmark. So, we have been working with good distribution practice. I've been working with it for most of my career, and seeing globally how different countries have adopted it, we were working with the HDA, and we have a program of auditing and really helping companies to bring up their standards. So, traditional companies that provide an accreditation for good distribution practice, it's often just a tick box exercise. 

[10:52] Amy Shortman: You'll have an auditor that comes along that has a list of things that they have to tick off. The next day, that same auditor could be auditing for health and safety or something else. So, what they, what they're doing is just saying, do you have this procedure? Yes, you do, that's it. Where we're very different is we actually understand, we have worked with pharmaceutical manufacturing, we've worked in logistics and air freight, ocean freight, road freight. We've run warehouses. So, we understand what's actually kind of needed. So why we're different is because we help, we train, but we also guide. So, if there isn't a documentation, if a trucking company is lacking a certain procedure, or they need something temperature-mapped, we'll actually help them to do that. We will help them, you know, write the standards, we'll help bring them up to the level that they should be. So, it's a lot more than just a consultant coming in and saying, you should do this. We actually really get our hands dirty and help them bring themselves up to those standards. So, the collaboration happened because there was a need in the US market. We could see that the, the adoption of the GDP standard were not happening. The pharmaceutical companies, of course, are global, so there was more and more awareness of what was happening in Europe and Asia that wasn't happening in the US. So, the HDA really kind of wanted to support their clients, their industry, and by doing that, getting the transportation providers really up to the same standard that they should be to be moving their products. 

[12:22] Amy Shortman: So, it's a partnership that we do. We couldn't do it without the HDA and vice versa. We work really well together, and we're taking that global knowledge, that real pragmatic understanding, because we know that not all trucking companies are the same, you know, not all facilities are the same. A warehouse in China or Asia is very different to one in Switzerland. So, we do take a pragmatic approach to implementing those guidelines, which I think really helps the people that we work with. They can see that we've done their jobs. We know and understand the environments that they're working in.

[12:56] Bill White: So, who benefits, I believe, we can all benefit from this, anybody that takes any kind of medication, and the confidence in the supply chain is certainly there once your best practices are put into place.

[13:13] Amy Shortman: Yeah, absolutely. So, you know, you've got now a program that's designed specifically and delivered by specialists from the industry. We are bringing up the transport Good Distribution Practice standards across the whole of the United States. To date, we have 13 companies that are accredited by the HDA. So, they've all gone through 3 levels of training programs. They've been audited. We now know that they are all working to those global GDP standards, which is fantastic. And we're translating kind of a GDP, which is a guideline system into that real life transport environment, which is really important because every product that moves through a trucking company moves down a highway. We want that to be in as perfect condition as possible when it reaches the customer. And that requires a lot of collaboration from industry. So, we can't do that without the evidence of a temperature monitor saying that it has maintained its temperature. We can't do it without the transportation company making sure that their trailer has been temperature mapped and has been calibrated and audited. Maybe there's temperature control packaging in there. So, it's really a combination of all these different parts that come together so that when we go as a consumer or we're in a hospital to a pharmacy and we're taking medicines, we know that that medicine is going to be as effective as possible.

[14:37] Bill White: Amy, this is all predicated on accurate information which begins in this context with the measurement of the temperature and other parameters as well, but temperature is critical, and very accurate measurement and acquisition of this information. How important is that?

[14:57] Amy Shortman: Yeah, I mean, anything from a quality point of view without evidence to prove what has happened, you know, it's a really important discipline that we have to have within the industry. It's critical for the quality release of products when it actually reaches the final destination to know that product has been transported within its temperature parameters. And I think that we've really evolved in the last 15 years as an industry with a lot of solutions out there that are able to provide very accurate temperature management and also a lower cost. Back in the day when I first started, they were very expensive, and now that price point's actually coming down that pharmaceutical companies, they have a bigger appetite for making sure more of the boxes that they're shipping, more of the products are temperature monitored with an individual monitor.

[15:48] Amy Shortman: The other thing that's really important there is the evolution of software development as well. So, alongside the actual physical device now, companies have fantastic software programs where you can actually get that information into the system, and once that reaches that final destination point, it's all there to kind of a big tick to say this has been maintained. And I think that that really is speeding up the supply chain, that's helping get products out to market quicker with that additional quality assurance. So, yeah, the industries really evolved, and I think that it's exciting to see where that goes in the future. My hope is that we can bring the price point down of devices so that more products have temperature devices in them, because that improves the quality. Back in the day, what they would do is tend to say, well, we have a summer and a winter profile of a shipment. And so that fall and spring would be OK if it was shipped under those circumstances. So, there was a little bit more kind of science around it where they created reasons for not having devices, and I think that's because they were, they were expensive. But that has changed and I think we'll see that only, only be improved going forward. Smaller, lighter devices and providing accurate real-time information.

[17:08] Bill White: And we know that uniformity and repeatability are critical. What happens when that breaks down? What happens when the data is incomplete, inconsistent? What's the remedy for that?

[17:21] Amy Shortman: I mean, the ability to retrieve data, you have to know that data is accurate as well, so the calibration of devices is really important. When anything breaks down and there has been a possible temperature excursion, of course the product can't be released and it can't go through its normal channels to get it out to whomever needs it. So that has a knock-on on the supply chain. It has a knock-on on confidence, you know, we see a lot of product-related shortages in the industry globally at the moment. We had big issues with this during COVID-19 pandemic because that was just sheer scale. But I think that knowing that the product has been maintained provides the customer and the doctors who are prescribing that medication a great deal of confidence. When that starts to wane or if product is, you know, stolen, put into an illegal supply chain, is then taken by a patient, which is a risk, and one of the reasons why the Pharmaceutical Cargo Security Coalition was created was really to prevent theft in the supply chain, to stop products being stolen and put on the black market because the company has an obligation from a brand point of view to make sure that no harm is done to patients.

[18:42] Amy Shortman: So, when we start seeing temperature excursions, things taken outside, and they're not monitored, they're not, we don't have evidence of that. They do get into a patient and cause harm that has a detrimental effect. It can cause, you know, licenses to be taken away to manufacture the goods, and it triggers a lot of brand impact for the company as well.

[19:03] Bill White: Can you comment on the need for that with respect to the regulatory environment, FDA 21, etc.

[19:10] Amy Shortman: Yeah, so the, the regulations are really clear that if a product states that it needs to be kept at a certain temperature for it to be effective, then there should be evidence of that when it's being transported. So, it's a critical part of it. And I think that the change in the appetite for that over the last 10 years has matured, which is fantastic, because now companies are really recognizing that it's important that we do monitor the temperature.

[19:40] Bill White: Amy, do you think we have the technology we need to get that done?

[19:44] Amy Shortman: Yeah, I think there's some fantastic companies out there. Obviously, Testo and other companies are producing products that are working to those FDA standards, and the information and the data that's coming from the devices into their software is accurate, which is really important, and so that the results and the information that they're getting out of that can be used to prove that the product has maintained temperature. So yeah, I think that there are, there's lots of different types and sizes of devices. I think one of the big things that's changed in recent years, less so the device in the product, but companies actually having to temperature map the inside of their trailers, that's a really big part of good distribution practice now making sure if they do have a temperature-controlled trailer and environment that they have evidence that that is keeping the product at the right temperature, that they do have regular calibrations of their equipment as well. And I think that area is expanding and companies such as Testo are able to offer services to support companies in doing that.

[20:58] Bill White: So, what's next, Amy? How will the GDP evolve and what should these transport companies, logistics people, what should they be getting ready for?

[21:08] Amy Shortman: So, I think that the future of Good Distribution Practice is about kind of continuous improvement, continuous control. It's not about sort of periodic checks. So, we like to think of it as less of a textbook exercise and more of, you know, it's not paperwork, it's actually patient protection happening every single day and I think the developments of real-time data or temperature control data and also, the involvement of companies, so the pharmaceutical companies are now starting to mandate in their RFQs that we should have good distribution practice, and that means that products should be temperature monitored. That means that a trailer should be mapped. It means that there should be adequate documents for procedures and standard operations procedures and the quality management system that all of that is housed underneath. So, I think it's about that the insurers are also getting involved now. They're realizing that there is a lower risk if a pharmaceutical company is giving products to transport and industry that is working to these standards, that are aware of what a temperature monitor is, and that are aware of you know, the mapping of the trailers. And, I think these things together will enhance the industry. So, we're moving from that sort of individuals doing it because they want to be, you know, the best for their pharmaceutical customer, that they have to actually it being an industry standard and a benchmark and an expectation.

[22:47] Bill White: And this involves land, sea, air, and global.

[22:51] Amy Shortman: Yeah, so Good Distribution Practice really is about any transportation. In the US, we have worked with wholesalers in the training and the auditing and getting, making sure everyone's working to standards, also anyone within the transportation industry. So yeah, it covers moving any product that's medicinal for human use once it leaves that sort of dock door of a manufacturing facility, and that can be to a wholesale, or it could be, you know, last mile to a patient.

[23:25] Bill White: So, from a corporate standpoint, someone responsible for all of this, how do they get in touch with you?

[23:32] Amy Shortman: So, the HDA, the Healthcare Distribution Alliance, is our partner in the US for running the Good Distribution Practice Program. Any companies out there that are working in transporting goods or wants to work within the pharmaceutical industry should start looking at these standards. We know that it's often, it seems to be when people look at some of the accreditations out there by other industry bodies, it can seem incredibly daunting. It isn't. Most of the companies that we're working with already have pharmaceutical clients. So, it's just really about making sure that everything is as it should be to the global standards. So often, it's not a big change for them, it might just be a few things that they have to improve on and make sure that the training is done to a broader standard within their organization. So, they can contact us at ASC or through the Healthcare Distribution Alliance as well.

[24:29] Bill White: Amy Shortman, ASC Associates, based in Cambridge, working around the world. Amy, thanks so much for being with the Testo Information Network today. We're really, really working hard to bring best practices in to position Testo in the leadership position for education and knowledge. You've been very helpful.

[24:54] Amy Shortman: Yeah, thank you so much. I mean, when education industry opportunities such as this, talking about it, and also accurate monitoring measurements come together, I think we can achieve more than compliance. We strengthen the trust across the entire supply chain, and that's really what we want to do. 

[25:11] Bill White: Amy, thanks so much. Thank you.

[25:18] Outro: You've been listening to Measuring Up: Thinking Out Loud, news and information from Testo, your resource for precision measurement technology and digital solutions for pharmaceutical, industrial, and allied industries worldwide.