A Generics Perspective: Teva Europe's Head of Quality Assurance EU Logistics on the Cold Chain Industry
In this exclusive interview Zvonimir Majic, Teva Europe, Head of Quality Assurance EU Logistics, speaks to Andrea Charles from Cold Chain IQ, about the increasing complexity of the pharmaceutical supply chain, focusing on supply chain integrity and how he expects temperature control logistics for the generics market to evolve in the next 2-3 years. Majic also shares his top tip for developing a centralised transportation and logistics model and his thoughts on implementing the revised GDP guidelines this September.
Cold Chain IQ: The pharmaceutical supply chain has gone through a dramatic transformation over the past few decades, with an ever-increasing number of players involved in developing, manufacturing, marketing, and distributing drugs. What current trends have you witnessed in the European pharmaceutical-distribution landscape? How have they impacted your role?
Z Majic: Today we do witness a considerably different shape of SC in pharmaceutical manufacturing. Complexity increased through several drivers such as micro and macro economics, global market reshape, regulatory landscape changes, increasing counterfeit market and so on.
Few years ago pharmaceutical industry could have been considered as an industry still immune to a certain global economic disruptions. This picture has changed and a need for a reshape and adoption to new business conditions and opportunities took place thus moving SC business environment towards new frontiers.
From a regulatory point of view a change impacting SC in Europe is recently perhaps more evident than ever with the publishing of new GDP guidelines. APIs are no exception in this respect either. We do see new regulatory requirements as an opportunity however rather than constraint of any kind. Practicising full compliance gives a sense of satisfaction and confidence because you know you are doing the right thing. . Every effort invested in this area is rewarded also through positive response and trends we see today in supporting industries such as transportation and logistics. Many of these positive trends are also happening under the umbrella of IQPC.
Another focal point continues to be integrity in SC of today. Obviously, contemporary SC expanding boundaries could get more vulnerable. I do believe we will see development in this area gaining dynamics.
Building a solid contemporary SC does not happen without addressing those important pillars.
Cold Chain IQ: How are you preparing for the implementation of the revised GDP guidelines in September?
Z Majic: I would say manufacturers are more or less already there. On the other hand, together we all strive to continuous improvement in all areas of business. We could consider this document as a good platform for bringing new values in distribution processes. Despite the fact guidelines will tell you what rather than how, personally I still see it as a garden of improvement opportunities which always brings added value at the end.
Cold Chain IQ: How is that?
Z Majic: Take for instance outsourced transportation and logistics mentioned before, one might say there lays a greatest challenge. I take this challenge as a chance for improvement. Change in perception of responsibility took place in the last few years. GDP guidelines are no longer perceived solely as manufacturer responsibility. We can recognize today signs showing transportation carriers understanding their roles in preserving patient safety through accepting responsibility and understanding their role in SC. Reaching this level is already a success compared to 10 years ago. Today we are more partners rather than just contractual parties. Dialogue level improved as well as industry expertise in handling time and temperature sensitive pharmaceutical products. My favourite example there is airline industry. In a last decade we succeeded in bring two highly regulated industries, pharma and airlines, together in a simple quest of keeping the goods away from long tarmac time. Only through an open dialogue did we manage to achieve this. It is then of course easier to address some of the challenging issues from the new guidelines in such a partnership environment.
Bringing manufacturers on the other hand to a common understanding of certain requirements could be considered a worthwhile effort in the future as well. This way our perception and output could be more uniform.
Cold Chain IQ: What would be your top tip for developing a centralised transportation and logistics model?
Z Majic: Let the transportation and logistics experts handle your transportation and logistics. We have a number of proven examples of so called Control towers around different industries. Centralization in addition enhances quality by having one group focused on requirements and compliance thus saving time and money.
Cold Chain IQ: The generic market is extremely price competitive, how do you manage your costs whilst maintaining quality in the temperature-sensitive pharma supply chain?
Z Majic: I believe having in mind quality, service level and costs in this order of appearance, safeguards company high level standards and preserve its future.
Cold Chain IQ: How do you see temperature control logistics for the generics market evolving in the next 2-3 years, what big changes can we expect?
Z Majic: My expectations are in the field of a new track and trace technologies finding their way and application in future SC. Major driver markets are mature enough in my opinion, let's hope economics will allow this development. Application of these technologies would improve traceability and add value in continuous focus on patient safety. Enhanced visibility in the supply chain consequently brings new quality standards.
Another area of change could again be regulatory environment. USP is about to deliver new GDP compilation document in the next year or two. We might still witness some Middle East and Far East countries further developing their regulatory environments as well. We could also see growing impact through responsibility shared further downstream in SC. Last but not the least; horizontal cooperation could gain momentum thus enabling building of a common, high standard business platform for the future.
You could picture future SC as air traffic control radar; dynamic, safe, high level controlled business environment supported by high-tech solutions.
Cold Chain IQ: I understand you are going to be speaking at the 13th Annual Cool Chain & Controlled Room Temperature Logistics Europe 2014, taking place in Luxembourg on 27-29 January. What are you hoping to gain from the event? What are you looking forward to?
Z Majic: 13th annual cool chain conference in Luxembourg will be another great opportunity for the different stakeholders in SC to get together and share experiences/best practices.
This will be a chance to gain insights into industry trends, cool chain logistics, supply chain integrity and latest regulatory changes. See you in Luxembourg.
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