Cold Chain Risks And How To Mitigate Them
An aging world population and the introduction of biotechnology-derived large molecules – requiring refrigerated storage handling at 2-8° – combined with expanding global market penetration has lead to notable growth in the size of healthcare cold chain logistics market. In fact, the global healthcare cold chain logistics market size is expected to grow from $8 billion (2014) to $11 billion by 2018, a third of which is expected to be dedicated to the area temperature-controlled packaging and service solutions.
Although the industry is growing, that’s doesn’t mean it’s without challenges. As emerging markets – all with long, complex shipping lanes requiring more stringent temperature control and monitoring measures to ensure product safety – become more prominent, managing risk has attracted more aggressive regulations. A number of influencers, including the European Union (EU), US Centers for Disease Control and Prevention and the World Health Organization (WHO), have strong regulatory stances for healthcare cold chain logistics and failing to meet any of these regulations could result in a loss of product efficacy, unwanted publicity and fines.
In the face of these stringent regulations, shippers and manufactures, which are ultimately responsible for examining their supply chains, should do so using a risk-based approach. This kind of approach involves both evaluation of the currency of the solution and possible sources of harm.
Source: Outsourced Pharma