Regulatory Compliant: Implementing E-Pedigree in a Global Company

Remaining regulatory compliant to ensure a global product delivery is vital when working with pharma packaging and labelling.  Ezri Deshen, Solid Operations Director at Teva spoke to Pharma IQ ahead of the Pharmaceutical Packaging and Labelling Summit, which is taking place in Basel, Switzerland in June this year.

Pharma IQ: Can give us an overview about implementing ePedigree in a global company.  What have the main challenges been for you?

E Deshen: The main challenges to running an ePedigree project can bedivided into three parts: 
  1. technology
  2.  the organisation
  3. vendors
Regarding technology, we're talking about complicated technologies that combine both engineering and IT and it starts from the specification and then the testing and the validation and the implementation, which combines technology, which is very complicated. 
The second part is the organisation.  In many cases, it's difficult to implement it and there are other priorities within the organisation, it requires a significant CAPEX, so there are many challenges that relate to the organisation itself. 
And thirdly the vendor where we're talking about the unique and the new technology.  There's not a lot of experience in the world and there's a limited number of vendors and their resources are quite limited, so we're facing a lot of challengeswith the vendors, so these are the main challenges that we are facing to a global ePedigree project.
Pharma IQ: What are the native regulatory requirements across the US?  I know that this is an area that you're going to discuss at the conference.
E Deshen: The regulations in the US have been well known for a long time and generally, we're talking about serialisation and the track and trace and ePedigree.  The challenges that we are facing with that is around the complexity of this technology, we are facing a lot of lobbying and questions and some speculation about whether they are going to be on time or not or perhaps further changes. 
Generally, our assumption is that the regulation will remain as it has for a long time, as I said, serialisation with aggregation, with ePedigree and we hope that there won't be significant changes. Changes in regulations add to our challenges.

Pharma IQ: Thank you, Ezri.  What are your own lessons learned from your current implementation in Teva? 
E Deshen: I think the challenges that I described in the beginning are  the issues that  I've faced and experienced in my projects running in Teva.  I think we are running that project in many sites and in different environments and the complications of the technology are also different because there's a difference in running this project in a manual line rather than running it in a fully automatic line. 
Of course, it depends also on how much the team is devoted and focused on the project, but in general, this project takes a lot of time. It takes time for the local sites to understand it and to understand where the challenges are, for example, at the beginning of the project, my understanding was that the main part of the project was engineering and later on, I realised that the main part of this project is IT, but at the end of the day, it's combined, so everything should be a combined effort.
A big learning point is that projects like this take time. We thought it would take 8 months, but in most cases it will take a year.

Pharma IQ: What is your approach to overcoming challenges of global supply?  Do you have a specific approach at Teva?
E Deshen: From the global supply chain, this is something that we're only at the beginning of because as we know, the manufacture is only the start.  The rest of the project will run from the wholesalers and distributors to the pharmacy. 
From my experience, they are the very beginning, so we've started our discussions with our customers of the supply chain, but it's really at the beginning.  The main thing here is how to convert SPUs from non-serialised to serialised and how to run the inventory, and, in some cases, how to run both in parallel, serialised and non-serialised; this is a very complicated project that involves the planners and the guys in the distribution centre and in the warehouse.
So I think, in the coming year, we are going to face a lot of challenges in running the project in the supply chain.
Pharma IQ: Finally, Ezri, what regulations do you think will affect the packaging industry in the next few years?
E Deshen: There's no doubt that the main regulation that is going to affect the industry is the EU.  There were some guidelines that were established in the EU in general, but now each country should adopt and put into a very clear law how they are going to implement it, so, in general, we are going to face that in the coming year.  I assume that by the end of 2013, there will be a clear picture of what, where and when it is going to be needed.  We have some estimations of what is going to be done, but they were not stipulated by law, and of course, once it is fixed and put into clear regulations, we will implement them, but I think the main one would be the EU.  Of course, we know that there are a lot of others, such as Chinese, Argentinian, Brazilian, Korean, so we're talking about something that is really going to be implemented globally.  One of the additional challenge is we're not talking about one global standard for all the regulations, but many regulations which are quite different from each other. 

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