Planning of product realization The manufacturer shall plan and develop the processes needed for product realization. Planning of product realization shall be consistent with the requirements of the other processes of the quality management system. In planning product realisation, the manufacturer shall determine the following, as appropriate:— (a) quality objectives and requirements for the product; (b) the need to establish processes, documents, and provide resources specific to the product; (c) required verification, validation, monitoring, inspection and test activities specific to the product and the criteria for product acceptance;Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India. (d) records needed to provide evidence that the realisation processes and resulting product meet requirements. The output of this planning shall be in a form suitable for the manufacturer's method of operations. The manufacturer organisation shall establish documented requirements for risk management (as per the IS or ISO 14971) throughout product realisation.Records arising from risk management shall be maintained.