Information technology is changing the way medicines are developed and used. Developers, manufacturers, regulators, academic groups and other stakeholders are working to develop a common understanding of where and how specific innovations, such as artificial intelligence and machine learning, can best be used in the drug development process. The assessment procedure is the main tool for planning processes and managing software tools at the stages of the life cycle of the drug manufacturing process. The approach to assessing process properties should be defined by a documented assessment procedure and may depend on the class of assessment, taking into account its objectives. The article discusses the key role of artificial intelligence models for assessing the processes of creating medicinal products. The principles and approaches that provide a meaningful and consistent basis for assessing process quality characteristics based on objective process implementation data are discussed.
Science Journal 