Regu;atory Perspective on Preparation of Post Approval Changes to drug Master Files

Abstract

Drug Master Files (DMF) hold vital information about the drug and it plays a key role in protecting the intellectual property of the company. To meet the requirements and demands of the stakeholders (i.e. DMF Holder and other industries taking advantage of the DMF), to keep up with the current trends of the industry, and to minimize the expenses and cost of manufacture, the lifecycle of the DMF is updated with the changes made in the process, ingredients, tests etc. The changes initiated by a department of the DMF manufacturer, undergo a thorough evaluation process performed by the cross-functional team members and the quality management personnel. The evaluation process essentially involves impact assessment and risk assessment of the change which ensures the change would have a minimum adverse effect on the established system as well as the quality of the final API. To ensure that the quality of the final drug product derived from the API is not compromised after these changes, it is important that the changes must be informed to the stakeholders taking advantage of the DMF. The changes made to the DMF are submitted as DMF amendments and contain only the information on changes made. This ensures that the authorities refer the updated and current information about the drug substance when evaluating the drug registration applications. This study summarizes and compares the post approval change requirements specific to the API DMFs in US, Europe, Japan, Australia, Canada and WHO