How To Bridge The Quality Gap In Your Climate Controlled Supply Chain

By Jeff Clark, President, 7PSolutions™, LLC

Over the last several years, organizations such as the World Health Organization (WHO), Parenteral Drug Association (PDA), and International Air Transport Association (IATA) along with most countries’ Ministries of Health or similar agencies have written guidance and regulatory documents regarding the handling and management of time and temperature-sensitive healthcare products during transport and in-transit storage. These documents are all very similar in scope, but they do have their differences. In response, pharmaceutical companies have been spending millions of dollars testing and validating shipping lanes, packaging solutions, and monitoring devices. That is in addition to the investments into education — such as attending cold chain and security conferences and hiring consultants to review, study, and counsel on data collected, routes utilized, preferred packing methods, and best practices.

All of these things are valuable and play a very important role in the development and implementation of best practices and processes within each pharma company’s supply chain. One must understand not only the stability of their products, but also the proper packaging solution for each mode of transport, and who are the viable solutions and service providers that have the expertise to maintain product integrity and security. However, as the pharma industry is testing and developing a greater number of products that will require even more specialized management and handling than in the past, it is important for all the players — including trucking companies, couriers, packagers, and other service providers — to understand the requirements to implement and sustain a quality supply chain. The requirements of controlled room temperature (CRT), humidity, light exposure, vibration, and worries of bioburdens and security must be considered and met throughout the entire climate-controlled supply chain — and all parties involved must be held accountable.