Purchasing 7.4.1 Purchasing process: The manufacturer organisation shall establish documented procedures to ensure that purchased product conforms to specified purchase requirements. The type and extent of control applied to the supplier and the purchased product shall be dependent upon the effect of the purchased product on subsequent product realisation or the final product. The manufacturer shall evaluate and select suppliers based on their ability to supply product in accordance with the manufacturer's requirements. Criteria for selection, evaluation and re-evaluation shall be established. Records of the results of evaluations and any necessary actions arising from the evaluation shall be maintained. 7.4.2 Purchasing information: Purchasing information shall describe the product to be purchased, including where appropriate— Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India Page 148 of 248 (a) requirements for approval of product, procedures, processes and equipment; (b) requirements for qualification of personnel; and (c) quality management system requirements.