Identifying and Managing Risks along the Cool Chain



Pharma IQ
06/19/2011

It can be a challenging task to identify and manage risks associated with the transportation of goods, especially pharmaceutical goods, which need stringent temperature controlled transportation. This cool chain management might pose a huge challenge as the pharmaceutical supply chain needs to be managed in accordance with the regulatory requirements of the European Union, among the member states. It is expected that there are going to be some changes, in order to provide more updated cold chain logistic solutions. Each link in the cool chain needs to adhere to the industry standards.

The volume of temperature sensitive products is increasing rapidly and with extensive global distribution networks and increasing regulatory scrutiny, there is greater visibility and demands on every link in the supply chain. Those in the supply industry should understand how to adopt practices to mitigate such risks. There are many non-profit organisations who address good cool chain management practices and manufacturers, regulators, suppliers and service providers can join such program to learn more about regulations, pharmaceutical standards, WHO requirements and also the current industry practices. Here they can listen to guest speakers from different countries and get direct industry questions answered. In such programs, many solution providers will be present and new tools and innovative solutions will be offered in order to mitigate risks for controlling temperature sensitive products in the cool chain. An opportunity to learn about specific projects with various case studies involving storage, handling as well as distribution of such temperature-sensitive pharmaceutical products, is also provided to the participants.

The selection and validation of cool chain partners is of utmost significance. These partners need to be reliable and even after this is verified, the supplier needs to set up an effective process in order to enable him to communicate and monitor the transport of the goods, so that an effective control over the temperature is maintained. There are many problems encountered between different partners during transportation. The last mile transportation can be particularly cumbersome, due to the presence of emerging economies. Ambient transportation from 15 degrees to 25 degrees is the focus of discussions. Aspects to be looked into are lot control,expiration date management, quality status and shipping of the proper lot to the proper customer within the stipulated time.

Managing risks along the cool chain can involve the use of alerts for tracking expiration date tracking with stringent accountability methods, by using electronic records and signatures. Risks can also be minimised along the supply chain by availing of proper and powerful software solutions throughout the supply chain. Risks can also be identified and managed by exploring the packaging solutions which provide better insulated performance. This can reduce freight costs. You can also consider differed scales, such as pre-filled syringes, ampoules, vials, pallets and containers and weigh the risks associated with each of these options. By comparing the size of the product against the size of the packaging, some problems can be minimised. All products should be properly conditioned and configured with the best quality packaging systems to be delivered with integrity. Temperature controlled packing solutions that are advanced should be availed.

The pharmaceutical industry is a stringently regulated industry and the safety throughout the supply chain is very important. Continuous validation has to be maintained throughout the operations by meeting the EU regulations and country-specific standards. You need to select partners fulfilling these validation requirements and implementing full compliance with the regulations throughout the supply chain.

For effectively identifying risks and managing them along the cool chain, the professional must make a thorough supplier assessment and improve selection of his transport partners. It is also suggested that they use RFID and TTI labels, in order to monitor the transportation and control the sensitive products. All industry standards and EU regulations must be stringently adhered to. Additionally, one can catch up on international case studies from various institutes and companies, to gain more tips on risk management.
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Having selected transport partners, it is also important to select the transport method, especially in case of international transport of temperature sensitive pharmaceutical products. It is important to know and analyse the variables that will have an effect on your project and implement strategies in order to secure safety for transportation on ground and air. Apart from identification of such aspects, core problems should also be analysed so that money can be spent appropriately and avoidable costs can be minimised, so that it can be redirected to other avenues of transportation and safety of the goods.

From the time the product leaves the warehouse, the supply cool chain should be monitored in order to optimise monitoring. Companies must also consider the pros and cons of various logistics suppliers and analyse the criteria for choosing a service provider. Monitoring should also be coordinated well along with the distribution partners. A good communication system must be put into place with the logistic suppliers, so that the cold chain is of good quality. It is also important to assess the cool chain requirements for all types of pharmaceutical goods according to individual specifications. Before choosing the management partners and transport solutions, you need to pay attention to identifying risks and requirements for transit and storage.

If there are any weak links in your distribution chain, then these should be identified and you must make an assessment of the risks involved and how they can be mitigated. This will minimise the risks and vulnerabilities involved in the supply chain. Having identified the risks along the supply chain, it is also necessary to make sure that the management system is being effectively followed by all the staff throughout the cool chain. Establish a proper strategy to be followed for evaluating the transport and the criteria to be considered. Al weak links should be first identified and then removed. There might be many risk factors to be addressed in management partnerships, in the packaging and also while dealing with outsourced providers. These should be properly monitored. A proper transport evaluation, involving shipping trailers and storage facilities and also a post-shipment analysis is necessary.

Other risks along the supply cool chain involve proper clinical supply partnerships with proper vendor coordination. The chain management must be efficiently managed with regard to costs and timeline and the available solutions in the market must be availed according to the guidelines and regulations. Suppliers should also brief themselves about case studies that provide effective solutions for managing risks. Such risks can involve delay which will result in changes in the optimum temperatures and fluctuations in the temperature, which might adversely affect the temperature-sensitive pharmaceutical goods being transported.


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