How to Develop a Compliant Cool Chain Quality System

Gwyn Murdoch, Director of Materials and Packaging and Labelling at Eli Lilly & Company, joined Pharma IQ, to discuss recent trends in the distribution of temperature-sensitive pharmaceutical products ahead of Cool Chain Europe 2011. To listen to the podcast now go to Developing a Regulatory Compliant Cool Chain Quality System.

Pharma IQ: Please could you tell us a bit about your current role?

G Murdoch: Currently I have responsibility for developing the global standards associated with the material system, which includes distribution as well as packaging and labelling in contract manufacturing. So in doing that we develop the standards that the rest of the global company need to follow in those arenas.

Pharma IQ: What recent trends have we seen in the distribution of temperature-sensitive products?

G Murdoch: Some of the recent trends that I've noticed is there are more of the smaller countries now demanding shipping to, for example, for refrigerated products 2 to 8°C with limited to no excursions. More and more of these small countries are basically holding product in their customs areas because there may be an excursion outside that refrigerated condition.

Pharma IQ: Why is it difficult for the industry to create global cold chain solutions? G Murdoch: I think the biggest difficulty is developing that cost effective solution, especially when you're shipping smaller quantities of material into countries such as Latin America where the amount of product you're shipping, the value of it, may not be worth using an elaborate cold chain solution. So it ends up becoming cost prohibitive to control the temperature within the desired ranges.

Pharma IQ: How are manufacturers addressing the challenges in developing a regulatory compliance cold chain quality system?

G Murdoch: I think the primary thing is developing a risk based approach and looking at your current shipping practices against timed temperature ranges that are based on stability data, versus shipping strictly to label claim. And again applying that risk based approach based on your practices, as well as what those regions and countries may be willing to accept.

Pharma IQ: Gwyn, what would be your top three tips for developing a risk management approach to evaluate shipping practices?

G Murdoch: I think the primary one is to ensure you've generated the appropriate stability data to support alternative shipping conditions or to support temperature excursions that may occur. And then also to evaluate the risk of shipping to any kind of alternative condition based on country and region expectations. Basically what one country may accept may not be acceptable to another country, so you really have to understand what your regulatory risk is and not design to the most conservative because, again, that adds cost and causes you to overprotect.

I think the other thing that I think this kind of group and this kind of conference, the role they play is to influence basically the regulators to open the door to alterative timed temperature ranges for shipping, since the duration of a lot of your shipments is very short and your products - based on stability data - can tolerate some level of excursion.

Pharma IQ: What do you think the global landscape for Cold Chain will look at in five years' time? G Murdoch: I think it can go one of two directions; I think the pendulum's going to swing in one of these two ways. It's either going to become extremely conservative and countries are going to expect that you ship to label claim with limited excursions, or the pendulum's going to swing the other way where countries are going to be more open to those alternative shipping conditions based on stability data.

I see that pendulum swinging for small countries in the more conservative way and for the larger countries swinging in the opposite direction. So I think it's critical to get the industry aligned on a standard set of regulations that everyone can follow, because we're not just shipping within one country we're shipping from country to country and it makes it very difficult when the regulations are not harmonised. Pharma IQ: For anyone interested in attending Cold Chain Europe, what would be your key take-home message? G Murdoch: I think the key take-home message would be, focus on a risk based approach for shipping based on science, and then be prepared to defend your position with the regulators.

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Interview conducted by: Andrea Charles

How to Develop a Compliant Cool Chain Quality System

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