Development of Bulk Shipping Studies in Pharmaceutical Industry

Abstract

Abstract ⎯ A bulk shipping study in the pharmaceutical industry consists in monitoring and analyzing the environmental conditions (e.g. temperature and relative humidity) during shipping and transportation of the drug product. The environmental conditions could affect the drug product critical quality attributes such as identity, strength, quality, and purity. The Company X needs to ensure that the shipping process and transportation does not affect the product X quality attributes i.e., safety, efficacy, strength, integrity and purity. The proposed method for this design project is the implementation of data loggers with the product during the shipping and transportation process to record the environmental conditions. Also to ensure that critical bulk product quality attributes are not affected with the exposed environmental and shipping/transportation conditions. Key Terms ⎯ Bulk Shipping Studies, Environmental Conditions, Mean Kinetic Temperature and Mean Relative Humidity