This document offers a thorough guide to regulatory requirements and best practices for Type IV Drug Master Files (DMFs) pertaining to excipients, as stipulated by the International Pharmaceutical Excipient Council (IPEC) and the FDA. Excipients, crucial components in drug formulations aside from the active pharmaceutical ingredient (API), necessitate DMF documentation to ensure medicine quality, safety, and efficacy. It stresses the importance of maintaining an updated DMF containing detailed manufacturing process information, controls, and technical data to uphold excipient safety and quality. Essential elements of a DMF submission include a transmittal letter, a commitment statement, and adherence to the ICH Common Technical Document (CTD) format. Procedures for amendments, annual reports, and change management are outlined, emphasizing the significance of GMP standards and streamlined CMC operations for excipients, impacting both APIs and drug products. Freyr, a global regulatory solutions provider, offers regulatory affairs expertise to aid life sciences companies in navigating these intricate requirements. The document concludes with recommendations for DMF maintenance, including the submission of significant change reports and annual reports to the FDA to prevent DMF inactivity.
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