Quality manual: The manufacturer shall establish and maintain a quality manual that includes— Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India Page 136 of 248 (a) the scope of the quality management system, including details of and justification for any exclusion or non-application or both; (b) the documented procedures established for the quality management system, or reference to them; and (c) a description of the interaction between the processes of the quality management system. The quality manual shall outline the structure of the documentation used in the quality management system. The manufacturer shall prepare documentation in a form of a Plant Master File containing specific information about the facilities, personnel and other details as prescribed in Fourth.