Plant Master File

The Plant Master File (PMF) under the Central Drugs Standard Control Organization (CDSCO) is a critical document required for the manufacturing of medical devices in India. The PMF provides a comprehensive overview of the manufacturing facility, detailing aspects such as site master plan, layout, equipment, utilities, and environmental controls. It also includes information on the quality management system (QMS) in place, adherence to Good Manufacturing Practices (GMP), and compliance with relevant Indian Medical Device Rules and international standards like ISO 13485. The PMF is essential for regulatory submissions, as it demonstrates the manufacturer's commitment to maintaining high standards of production and safety. A well-prepared PMF facilitates smooth regulatory approval, ensuring that the manufacturing site is capable of producing medical devices that meet the stringent requirements of the CDSCO. This document is a key component in the regulatory pathway, aiding in the assessment and inspection processes, and is crucial for obtaining manufacturing licenses under CDSCO regulations. Accurate and detailed documentation within the PMF not only supports compliance but also enhances the credibility and reliability of the manufacturer in the competitive medical device industry.

According to the fourth schedule of the MDR 2017, The manufacturer shall prepare a succinct document in the form of site master file containing specific information about the production and/or control of device manufacturing carried out at the premises. It shall contain the following information,-