By Niranjan Kulkarni, PhD, Director of Operations Improvement, CRB
To ensure quality of pharmaceutical raw materials and products, it is very important to monitor specific factors throughout supply chain. In cold chains, temperature is closely controlled and monitored.
Cold chains are supply chains where temperature, and in many cases humidity, is controlled and monitored. Pharmaceutical components like Active Pharmaceutical Ingredients (APIs), biologics and vaccines, are all handled through cold chains. These chains are much more difficult to manage compared to the traditional supply chains due to several factors including, controlling temperature/humidity of materials (raw material, drug substance or drug products), continuous monitoring and accurate reporting, material shelf-life, stringent checks imposed by regulatory bodies, high probability of drug counterfeits, etc.