Monitoring and measurement of processes: Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India Page 155 of 248 The manufacturer shall apply suitable methods for monitoring and, where applicable, measurement of the quality management system processes. These methods shall demonstrate the ability of the processes to achieve planned results. When planned results are not achieved, correction and corrective action shall be taken, as appropriate, to ensure conformity of the product. 8.2.4 Monitoring and measurement of product: 8.2.4.1 General requirements The manufacturer shall monitor and measure the characteristics of the product to verify that product requirements have been met. This shall be carried out at appropriate stages of the product realization process in accordance with the planned arrangements and documented procedures. Evidence of conformity with the acceptance criteria shall be maintained. Records shall indicate the person(s) authorizing release of product. Product release shall not proceed until the planned arrangements have been satisfactorily completed.