Stability Data in the Cold Chain

Cornelia Nopitsch-Mai, scientist for the Federal Institute for Drugs and Medical Devices in Germany, discusses good distribution practices in cold chain management. To listen to the full interview go to How to Implement Cool Chain Regulations Effectively in Order to Ensure Full Compliance.

Pharma IQ: What are the current key initiatives for good distribution practices in cold chain management?

C Nopitsch-Mai: I think in this case it's the Inspectorate. It doesn't belong to the quality assessment. It's clearly stated that this is the good distribution practice which belongs also to good manufacturing practice and therefore the Inspector has to look for the regulatory issues. It's not a quality issue at that time; it belongs more to the Inspectorate.

However, if we can see that something is transported or shipped from let's say one outside Europe, from one climatic zone to another climatic zone, maybe in this case we will ask something about the shipping conditions, but only in these cases and not regularly. It's not a requirement for the quality assessment.

Pharma IQ: Regulatory compliance is key; what would be your top tips for implementing cold chain regulations effectively?

C Nopitsch-Mai: First it's the stability data which supports the need of cold chain transportation and to provide also data at accelerated conditions, let's say for short time, for example at five degrees, and also to provide also data on stress testing, like product stability or data under heat and humidity.

Pharma IQ: What are the key stability issues for pharmaceutical bulk products and how should we seek to overcome them?

C Nopitsch-Mai: I think it's necessary to give details of storage conditions and also on container closure systems, because these are the main issues we have to look for for stability data. So we have the guidelines on stability data on new drug products and new drug substances and also for existing drug substances and drug products. In this guideline no conditions are mentioned for the shipping conditions or cold chain conditions, they are not mentioned or only some parts, some issues are mentioned in these guidelines. But mainly it's up to the pharmaceutical company to establish such kinds of conditions and to describe the condition that the bulk-ware, for example, has been stored and also, of course, the container closure system.

Pharma IQ: Cornelia, what do you think the future holds for European pharmaceutical cold chain distribution?

C Nopitsch-Mai: I think maybe it will become an issue which has to be assessed also by quality assessors and not only by inspectors, so to work closely together with inspectors. I think this may become, in the future, one of the issues regarding stability data.

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Interview conducted by: Andrea Charles