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Quality management of cold chain logistics presents many challenges for the pharmaceutical industry. While an internal quality management system can efficiently target a company’s own operations, logistics takes place outside of company premises and will to a certain extent be out of the company’s control. Still, pharmaceutical companies will be held accountable should anything go wrong while the products are being shipped to their final destination. With so many stakeholders involved – forwarders, ground handlers, airports, airlines and subcontractors – how can pharmaceutical companies ensure that they are following procedures and comply with regulations? Building operational excellence will be a key to overcome logistics challenges in this scenario. But first, we will take a closer look at the actual challenges:
1. No single Good Distribution Practice for the pharma cold chain
With a global market, regulations for temperature-controlled transport differ in different countries and regions. Since regulators audit the pharmaceutical company, the company has to ensure that all stakeholders of the logistics chain comply with regulations. But how can they audit their external service providers? This will be an increasing challenge when designing a quality management system. The EU Good Distribution Practice, GDP, is successively being implemented in more countries, which could result in a standardization of the logistics chain. The US will however implement its own version of GDP, which means that we cannot expect a single global standard.
2. Guidelines are becoming more specific
While the number of guidelines is perhaps not increasing per se, the guidelines are becoming more specific and stricter. Pharmaceutical companies will simply need more data regarding their transports, especially when it comes to temperature-sensitive products. In the end, safer transports will benefit consumers, but this development puts higher demands on companies, as they will need to prove the quality and safety of the transport from start to finish.
3. An internal audit plan with more focus on logistics
Historically it was primarily the manufacturing of pharmaceutical products that had to be monitored on a continuous basis. Now and in the future, logistics will need continuous monitoring in order to comply with regulations. A structured internal audit plan will therefore have to include internal audit checklists and tools for auditing external logistics providers.
An internal audit plan is not just about complying with regulations; it is also a tool for developing the operational excellence strategy by streamlining operations and troubleshooting. A comprehensive operational excellence strategy has to include risk management of temperature-controlled logistics to a greater extent today than yesterday.
4. Unforeseen events will have a greater impact
With an increasing amount of temperature-sensitive products, unforeseen events during transport are a growing challenge. No matter how strict the control of service providers is or how good the alignment of the logistics chain is, there will be customs delays, strikes, typhoons, containers that are dropped from a forklift and packages that are left on the tarmac in extreme hot and cold temperatures. Whatever shipping solution is chosen, specifically for sensitive pharmaceuticals, it will also have to account for these circumstances and mitigate their associated risks. Temperature-controlled logistics is hence an area that quality managers need to put more focus on; it should be part of the internal audit plan and is critical for operational excellence.
5. More product stability data required for sensitive pharmaceuticals
Product stability data is needed in order to choose the optimal logistics solution. Is the product sensitive to high temperatures, low temperatures or light? Shock and vibration is another issue on the rise. Based on the product requirements, a risk profile can be developed, which will be used for validating different stages of the transport, such as temporary warehousing, temperature-controlled containers and ground handling. As the last years have seen an increase in biopharmaceuticals and other temperature-sensitive products, this is an additional challenge when developing an operational excellence strategy that includes logistics.
6. Increasing need for a more stringent validation of shipment solution
As mentioned above, based on the product risk profile, warehousing and containers/packaging solutions must be validated to meet product requirements. Qualifying the shipping solution can be time consuming. Some providers of temperature-controlled containers and other packaging solutions provide technical documentation, which will simplify and speed up the qualification process. In addition, environmental testing chambers can be used to simulate temperatures and humidity levels of the specific shipment route.
Envirotainer Cold Chain Laboratory
Test how a shipment is reacting to a specific temperature scenario – in a controlled environment.
7. More detailed data required for operational excellence
Securing reliable data for a post shipment analysis is a prerequisite for achieving operational excellence of the pharmaceutical cold chain, not least with the increasing amount of temperature-sensitive products. Furthermore, most guidelines include a clause for continuous improvements and thus, reliable data on shipments must be secured on a continuous basis. Some service providers offer shipment data such as ambient temperatures and temperatures inside the container, humidity levels and if the container has been opened. This kind of data is essential for understanding the weak stages of the logistics chain and is imperative for operational excellence.