Manufacturing processes: Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India Page 120 of 248 The device master file should contain information to allow a reviewer to obtain a general understanding of the manufacturing processes. It is not intended to take the place of the more detailed information required for a QMS audit or other conformity assessment activity. The information may take the form of a process flow chart showing, for example, an overview of production including the technologies used, assembly, any in-process and final product testing, and packaging of the finished in vitro medical device. 5.3 Manufacturing sites: The device master file should identify the sites where these activities are performed (this does not include the sites of all suppliers of raw materials but only the sites that are involved in critical manufacturing activities). If Quality Management System certificates, or the equivalent, exist for these sites, they may be annexed to the device master file