How to Maintain Your Day-to-Day Cold Chain Process

Pharma IQ spoke with Almut Malone of Global Logistics Clinical Supplies at Bayer Schering Pharma AG, on how her department maintains their day-to-day cold chain process.

How do you at Bayer Schering implement a strategy of ongoing evaluation in regards to your global shipping logistics?

Our logistics department only deals with distribution of IMPs, which come in much lower quantities, but in different packaging and in sometimes larger volumes than marketed drugs. We collect and review shipment data on a regular basis in order to be ready for any possible emergencies. We also routinely review all data obtained following any change in the distribution process, such as courier handling or shipper configuration for a defined number of shipments.

When organising logistics on a global scale, how do you deal with the task of compliance to a wide number of regulating bodies?

For clinical trials, we publish the status of country-specific requirements, such as import preparation, on our intranet. Prior to the start of a new study, these requirements are verified by a responsible person and any updates or changes fed back to our logistics group. This is also done on an ongoing basis.

What are the most common instances of failed shipments within the handling of products along the clinical supply chain, and what processes are in place to minimise the fallout of these occurrences?

In clinical trials, the number of "failed shipments" must be reduced to the possible minimum, because there is not always sufficient stock to replace unusable supplies. Our processes are therefore set to avoid all potential causes of failure up front. Therefore, real failures (those leading to the rejection of a shipment) are relatively rare and usually have uncommon and unpredictable reasons, which are thereby thoroughly addressed to avoid repeat incidents.

When re-designing your packaging, what areas were looked to be improved, and what materials have been found that best meet the rigorous requirements?

For various reasons, multi-use shippers are considered only when using a premium courier service. There was significant room for optimisation with regard to the single-use shippers offered as the standard solution by many commercial depots. These standard shippers often turned out have been inadequately tested and to be of low quality material. We therefore focused on improving the components used and had our testing profiles applied to them.

How do you feel the cold chain industry is progressing in terms of technology and experience? Are we moving at a fast enough pace to keep up with demand?

As there are different types of suppliers and service providers branching from that industry, I do not believe this can be answered concisely. It would however be very helpful for the vendors and the users to agree on common worldwide state- of-the-art industry standards.

In terms of balancing costs, what areas would you say require the most investment to improve overall temperature-controlled shipping?

The best investment is always in the area of minimising human error and achieving awareness across all parties in the requirements of handling such goods.

Finally, what are the long terms goals that your department is hoping to achieve?

We hope to establish a set of tailored solutions for the worldwide distribution of our study drugs, from which the next user can then make a selection according to their own specific needs.