Implementing a cold chain strategy for a new market or climate zone can have many challenges, such as, adapting the cold chain to meet new regulations, geographic distance and varying validation processes. In some cases, just identifying the risks for your cold chain can be extremely challenging, as Pharma IQ found out when speaking to Geoff Glauser, Director of Global Packaging Technology for Wyeth.
He said: "As you go through the supply chain and the transit chain for temperature sensitive products identifying the significant risk, can be the most challenging event. It’s not so much that the identifying comes down to anyone carrier or anyone transition period, but really identifying where the hang ups and hold ups may potentially be, and the ones that are actually happening within transit. With most of the planning you do, you can never necessarily elicit the exact response you have with risks. So keep your eyes and ears open and look for the unusual."
Packaging solutions
Once you have identified your risks, the next challenge is how to mitigate risk with the lowest cost possible. Are you able to reutilise packaging solutions or methodologies and save money? If you are only transporting a small amount of product, this may turn out to be the most cost-effective strategy. However, if you are distributing a product on a large scale, it may actually prove to be more cost-effective to have a tailored cold chain solution.
Drug manufacturers must work together with 3PLs, packaging specialists, warehouse operators and transport providers, to ensure quality control and validation along the cold chain. With so many players involved, relationship management is a key factor for successful entry into a new market or climate zone.
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Exporting
The demand from the pharmaceutical sector is high, and governments must also take stock. Effective cold chain logistics are critical to a country’s future export success. They need to ensure that their ports and facilities are as attractive as possible to manufacturers, 3PLs and transportation providers.
Packaging specialists also need to realise there has been a shift in recent years. Industry not only requires that packaging meets certain pre-defined performance criteria, but that manufacturers are looking for a one-solution fits all when exporting their products to different climates, a single pack to suit multiple hemispheres.
Large countries and geographic distance
Climate is not just an external challenge for cold chain, internal distribution channels can also be greatly affected. In an interview with Pharma IQ, Andrew Meyers, Managing Director of Global Chain Solutions said: "In large countries there are also multiple temperatures and climate range, so it is very difficult if you are using a central distribution to cater for all geographic areas."
Meyers also spoke about how the global recession has led to a reduction in transportation services, and how this has become a problem for large countries. He said:
"One of the recent problems is the global recession, and this has added further complexity with large countries, and large distances such as Australia. Many of the regional airlines are reducing flights, so it is not just the climate, it is also the geographic distance which is creating some problems within cold chain, and it would be the same in continents such as, the US and Europe."
Validation
Validating a whole cold chain is a very complex task. Many validation methods are defined in-house and vary significantly from manufacturer. The integrity of the temperature monitoring data is often an issue, as equipment is not always suitable for the purpose that it is used. It is crucial that manufacturers study the validation process very carefully, to ensure that meets their specific requirements.
Companies need to take a global perspective to cold chain, or undoubtedly they will have cost efficiency issues. This was reiterated by
Meyers said: "Implementing a cost-effective, validated cold chain or supply solution is a difficult area, and this is due to the number of variables, which change dramatically depending on which path you take. So done correctly cost can be kept under control, but my only advice to people is don’t take an isolated view of it, you must take global approach."
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