Temperature Excursion Management in Cold Supply Chain of Pharmaceutical Products

Abstract

India’s cold chain industry is currently estimated to be worth $8 million which is composed of a combination of refrigerated transportation and surface storage mechanism. Managing the quality of pharmaceutical product during cold supply chain and the distribution process is a complex challenges for the pharmaceutical industry. The Indian cold chain market is anticipated to be more organized in setting up the cold chain facilities across India in coming years. The temperature  should be maintained for the storage and transportation of temperature sensitive goods during the entire product life cycle right from the receipt of raw material and its manufacturing till distribution. There is a need of special handling and monitoring of the refrigerated product to ensure the proper packaging configuration and transit methods meet the predetermined cold chain criteria. Improper handling might deteriorate the quality of the product thereby lowering the therapeutic properties. The study focuses on a system based quality management in pharmaceutical operations, quality assurance and enhancement, concerted efforts, concepts, consequences and handling mechanism to ensure product quality.