srihari karrothu

Process Research and Development of several API’s for USP & Ph. Eur. and Intermediates. Providing suitable scientific justifications, identifying the route cause, recommending the corrective and preventive actions for the batches which were confirmed as out of specifications, out of trends and Deviations to meet current regulatory requirements demanded by U. S. Food and Drugs Administration (USFDA) and International organization for standardization (ISO). Systematic investigation of root causes of identified problems or identified risks to prevent their occurrence or re occurrence Implementing the Quality by Design (QBD) principles: By identifying Target Product Profile (TPP) and Critical Quality Attributes (CQAs) development of new process was carried out by identifying the Critical Process Parameters (CPPs). By using design of experiments (DoE) number of parameters was reduced to a practical and sensible level.