Building Quality into the Crystallization Process
Crystallization processes, especially for final API isolation, serve as quality-control steps for API products. These processes should be designed and controlled to meet predefined product quality attributes to ensure the safety and efficacy of the final drug product as required by government regulators. 1Cerulean Associates, Why Quality by Design? An Executive’s Guide to the FDA’s Quality by Design, March 2008, https://ceruleanllc.com/wp-content/articles/eReport_QbD_Executive_Guide_CERULEAN.pdf. But even today, many chemists and managers in the pharma industry regard crystallization processes as more of an art than a science. CfPC takes the opposite view. It believes that rigorous application of relevant scientific and engineering principles to each aspect of the crystallization process not only builds in quality but also increases the efficiency and stability of the process itself.