Production and service provision 7.5.1 Control of production and service provision: 7.5.1.1 General requirements The manufacturer shall plan and carry out production and service provision under controlled conditions. Controlled conditions shall include, as applicable:— (a) the availability of information that describes the characteristics of the product; (b) the availability of documented procedures, documented requirements, work instructions; and reference materials and reference measurement procedures as necessary; (c) the use of suitable equipment; (d) the availability and use of monitoring and measuring devices; (e) the implementation of monitoring and measurement; (f) the implementation of release, delivery and post-delivery activities; and Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India. (g) the implementation of defined operations for labeling and packaging. The manufacturer shall establish and maintain a record for each batch of medical device or in vitro diagnostic medical devices that provides traceability and identifies the amount manufactured and amount approved for distribution. The batch record shall be verified and approved.