Determination of requirements related to the product: The manufacturer shall determine-— (a) requirements specified by the customer, including the requirements for delivery and post-delivery activities; (b) requirements not stated by the customer but necessary for specified or intended use, where known; (c) statutory requirements related to the product; and (d) any additional requirements determined by the manufacturer. 7.2.2 Review of requirements related to the product: The manufacturer shall review the requirements related to the product. This review shall be conducted prior to the manufacturer's commitment to supply a product to the customer and shall ensure that— (a) product requirements are defined and documented; (b) contract or order requirements differing from those previously expressed are resolved; and (c) the manufacturer has the ability to meet the defined requirements. Records of the results of the review and actions arising from the review shall be maintained. Where the customer provides no documented statement of requirement, the customer requirements shall be confirmed by the manufacturer before acceptance. Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India. Where product requirements are changed, the manufacturer shall ensure that relevant documents are amended and that relevant personnel are made aware of the changed requirements.