Planning 5.4.1 Quality objectives: Top management of the manufacturer shall ensure that quality objectives, including those needed to meet requirements for product, are established at relevant functions and levels within the manufacturing organization. The quality objectives shall be measurable and consistent with the quality policy. 5.4.2 Quality management system planning: Top management of the manufacturer shall ensure that— (a) the planning of the quality management system is carried out in order to meet the specified requirements, as well as the quality objectives; and (b) the integrity of the quality management system is maintained when changes to the quality management system are planned and implemented. 5.5 Responsibility, authority and communication 5.5.1 Responsibility and authority: Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India Page 139 of 248 Top management of the manufacturer shall ensure that responsibilities and authorities are defined, documented and communicated within the manufacturing organisation. Top management of the manufacturer shall establish the inter-relation of all personnel who manage, perform and verify work affecting quality, and shall ensure the independence and authority necessary to perform these tasks. 5.5.2 Management representative: Top management shall appoint a member of management who, irrespective of other responsibilities, shall have responsibility and authority that includes— (a) ensuring that processes needed for the quality management system are established, implemented and maintained; (b) reporting to top management on the performance of the quality management system and any need for improvement; and (c) ensuring the promotion of awareness of regulatory and customer requirements throughout the manufacturing organization. 5.5.3 Internal communication: Top management shall ensure that appropriate communication processes are established within the manufacturing organisation and that communication takes place regarding the effectiveness of the quality management system. 5.6 Management review 5.6.1 General: Top management shall review the organization's quality management system, at planned intervals, to ensure its continuing suitability, adequacy and effectiveness. This review shall include assessing opportunities for improvement and the need for changes to the quality management system, including the quality policy and quality objectives. Records from management reviews shall be maintained.