To ensure the quality of pharmaceutical raw materials and products, it is very important to monitor specific factors throughout the 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.
Different materials require different storage conditions, e.g. ambient, less than ambient (chilled), below freezing, or sometimes may even require temperatures < -160C (cryogenic). Extended periods of transit time increases the risk to product quality by increasing the probability of exposure to temperature excursions, humidity, light or atmosphere. Slight temperature excursions outside the pre-validated condition, for brief periods, may be acceptable provided stability data and scientific/technical justification prove that product quality is not affected. However, any significant deviations from this validated temperature range can significantly impact product quality. Thus, it is very important to control, monitor, report and document temperature attributes constantly throughout the chain. Inaccurate and untimely recording and reporting, or loss of information at the handoff points can result in significant penalties (monitory or legal) for the supply chain players. To improve supply chain visibility, better communication between different nodes involved with the supply chain is essential. Information regarding demand data, sales, capacity levels, inventory, etc. is shared within the supply chains, including the cold chains. Along with the aforementioned information artifacts, we also need accurate and timely information exchange at the handoff points between echelons in the cold chain.
A recently published paper by CRB, in association with Savanna State University, describes the development of dynamic equations for a four-echelon network structure, with the potential to be expanded to multi-echelons. Additionally, a design of an experiment was created and a simulation-based optimization study was performed to understand the sensitivity of supply chain ownership, stochastic demands and probabilistic information transmission conditions on the overall cost for the pharmaceutical cold chains. This is a unique feature of the research as there are no studies that have used ownership cost and information transmission as factors to model a supply chain under a simulation optimization environment for the pharmaceutical environment. Outcomes from this study are expected to provide important insights into cold chain management issues and help companies make better decisions.
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