Tony Wright: Building and Maintaining Integrity is the Number One Supply Chain Priority

Good cold chain management always starts at the beginning. In this Cold Chain IQ interview Tony Wright, Chief Executive Officer of Exelsius Cold Chain Management., shares his insights on supply chain integrity, the impact of the revised EU GDP guidelines and understanding the end to end process. Wright also reveals the current knowledge gaps in the market and his top tips for auditing a supplier.

Cold Chain IQ : Globalisation is placing increasing trends on temperature control supply chains. What trends are you witnessing?

T Wright: I think there's no question that supply chain integrity – and the use of that word, integrity, is on the lips of most regulators, and in turn on the lips of those key stakeholders in the pharma supply chain. Temperature control remains a very crucial part of the process of integrity, and, clearly, transportation is now viewed, particularly by regulators, as just an integral part of the supply chain. So that integrity needs to be at the same high level, regardless of whether the distance between manufacture and point of sale is 100 miles or 10,000 miles. What I've seen is particular trends in data management that support that need for integrity, and also greater demand from countries around the world for the use of data loggers to provide the necessary evidence of that integrity. So it really goes back to this word, supply chain integrity. And I think, equally, we've all seen the trend towards management of controlled room temperature. That rather inadequate phrase, I think, that's often used to determine temperature management between 15 and 25 degrees centigrade. So that seems to be gaining ground. As, I think, there are trends in the industry towards minor shifts in modes, particularly for that 15ºC to 25ºC, perhaps towards more distribution. So I think we've seen some emerging trends, but I think the one I'd stick out with as being most important is that supply chain integrity.

Cold Chain IQ: What impact are the revised EU GDP guidelines having on the industry?

T Wright: I think the first aspect that's been heightened is the question of responsibility. The revised EU guidelines that came into effect last September have placed a much clearer responsibility on the part of manufacturers and wholesalers to be not just better aware of their supply chains, but also to be able to audit them. The role, for example, of the responsible person that is now a much clearer partner of regulations, has really boosted that aspect of responsibility and being able to audit, through that person having control, for example, of quality management systems. I think also, in terms of logistics for example, for the larger global logistics players who had already been offering very well controlled GDP compliant services, the change in the regulations has, perhaps, been minimal. However, those smaller logistics players, of which there are quite a number, have perhaps had a wakeup call to become GDP complaint, if they're going to continue to play a role in offering pharma-specific services. And I can attest to this, really, from the point of view that Exelsius witnessed a peak in demand for its gap analysis education and development of SOP services from those smaller companies. As well as pharma companies looking to know how they can be sure that they can create good relationships and good service level agreements with their suppliers. I think, overall, the EU guidance has to be viewed, really, that any improvement in guidance that creates greater supply chain integrity really has to be a welcome step. Maybe it's work in progress, but I think it's a good welcome step. [inlinead] Cold Chain IQ: When it comes to compliance, do you think that the industry is keeping pace?

T Wright: I think it's a mixed picture. I think there are clearly some great examples. For example, the Luxembourg recent GDP Certification initiative. That has placed a clear marker in the sand in terms of keeping pace. But there are gaps, there's no doubt about that. The weakness, perhaps, is not in what is available in terms of temperature controlled solutions, because, clearly, there is a vast array of active and passive packaging products and data management services. We only have to look at IQPC's event in Luxembourg to see how many players were there. So the tools about compliance are there, but it's the awareness; it's the knowledge and the general lack of understanding that, I think, is not keeping pace with the needs of compliance. When it comes, for example, to even understanding in some cases the actual existence of transport regulation, it still alarms me how low the awareness can be. Though I would be the first to confess that it does vary from region to region.

Cold Chain IQ: You run a variety of training courses for distribution in temperature controlled sector. Where are you seeing the biggest knowledge gap?

T Wright: I think that's a very interesting use of the word, knowledge gap. And I take you back to it was Benjamin Franklin who once said that an investment in knowledge always pays the best interest. So it is, I think, with education and training in this sector. What concerns me most is the lack of real end to end supply chain awareness by the various stakeholders, who really do need to step up and be better aware of how their products get to market. We often conduct education services in gap analysis that really does show the lack of understanding and the gaps that are in existence about people's awareness of how products really get to market. People tend to know their part, but not too much beyond their part. Therefore, it's difficult for them to see the bigger picture. I think you have to say that the EU regulations have gone some way to improve this, but it still needs to be driven, with the realisation about that responsibility that I spoke of earlier. For me, the biggest knowledge gap is in that general appreciation of end to end process. It's not any longer a case that participants can just know their part. Good cold chain management always starts at the beginning. It always starts with the shipper, and I think we need to see much greater awareness of how and what happens, and make significant changes in that entire process.

That's why our training, the training that we've done to over 100 individual companies around the world now, close to 1,000 people have attended some form of training from us. It always takes that holistic approach. It always looks end to end, making sure that we create the knowledge and awareness that goes on in the entire supply chain. And we always start our training by telling people that unless they understand what's in the box, they can't get a real appreciation of how to handle that box. So those logistics players need to understand the pharma sector much more and the pharma sector needs to understand the logistics sector much more. The gaps are beginning to close, but there's still some work to do.

Cold Chain IQ: What would be your top tips for auditing a supplier?

T Wright: I think the first thing I would say is don't look first at the temperature controlled facilities. Don't look to see whether they've got good temperature management facilities, good temperature control, good storage. Don't look at that first. Look at their quality management system. For me, the quality management system is the beating heart of their business, and I think that should give any company auditing a supplier a really good early indication about their ability to comply. If they can demonstrate a well managed, well controlled quality management system that's really inclusive, then I think that's a really good first step towards seeing that you've got a supplier that can meet your obligations.

As you might expect, I'd also say ask to see their training records. And not only their training records but also the syllabus of their training courses. In other words, ask for evidence of who has been trained and when. And what subjects were covered. That way, I think you can be sure that the training was relevant, the training is up to date, and that the team managing your products are capable of handling them to your requirements. And finally, probably, the other tip I'd give is about SOPs.

I think the final tip would be around looking at SOPs. Are they really in use? I've seen so many examples of written SOPs that are not practised. And I think, again, before you get to the hardware of looking at facilities, look at the SOPs. Make sure that they are still relevant. Most SOPs fail because, in some respects, no one knew that they actually existed. So I would look at those three areas before I started to look at the hardware.

Cold Chain IQ: In your opinion, what are some of the barriers to innovation in the pharmaceutical supply chain?

T Wright: What I've seen over the last few years is that the pharma supply chain is not afraid of innovation, perhaps for a number of reasons. Clearly, there's been some regulatory pressure that has made them look for innovation in supply chains, and there's also been economic pressure that has made them look for innovation. I'm not so sure it's about barriers. But we need, really, I think, much greater harmonisation in terms of some of the standards that are in place. I think sometimes we see a logistics sector that is trying hard to focus on the pharmaceutical sector, and sees lack of harmonisation in terms of standards, lack of harmonisation in terms of even the basic things of temperature scales. I think the logistics sector needs a level playing field for it to really work effectively. For me, it's not about barriers. I've not seen barriers not being dismantled. I've seen just the need for creating a better field for people to play in, and to make sure that we harmonise all the things that we're trying to do in the supply chain. We need to bring all those participants together. Cold Chain IQ : Why were you keen to share your thoughts at Cool Chain Russia and CIS 2014 ?

T Wright : There were a number of reasons. Russia, for most people, I think, represents both a challenge and an opportunity to the pharma and the biopharma sector. Its economy has not produced sufficient home-grown businesses. And it's, therefore, I think, from my research, a little way behind western economies in this sector. I read an article recently by Pharma Exec that said it hadn't produced a single world class medicine for sale outside its own borders. So it is a little way behind Western European in terms of its appreciation of pharma supply chains. Where import products are therefore in demand, there is, clearly, the big challenges of distribution over such vast distances, over such extremes of temperature. And I think the industry there has been slow to appreciate the needs of good temperature management. Perhaps the awareness that we talk about in the western world, around supply chain integrity, is perhaps generally low in Russia.

In that sense, I saw an opportunity to use what we've done so far to try and improve this awareness, and, through our consulting education and research services, the opportunity to satisfy a need to extend this to a market that faces, from what I can understand, real challenges both in finished products and also in clinical trial markets. So for me, I'm looking forward to sharing that expertise, to understanding how we can improve the supply chain integrity that exists, and I really look forward to being in Cool Chain Russia and to meeting some key industry players.

Cold Chain IQ: Thank you very much, Tony, for sharing your insights and your time with us today. We look forward to hearing more from you at the Cool Chain Russia event.

If you would like to find out more about this topic and the Cool Chain Russia event, this 23rd to 25th April in Moscow, Russia, visit our website at www.coolchainrussia.com .