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2023-05-26T05:19:53
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The manufacturer shall ensure the adequacy of specified purchase requirements prior to their communication to

The manufacturer shall ensure the adequacy of specified purchase requirements prior to their communication to the supplier. To the extent required for traceability, the manufacturer shall maintain documents and records of relevant purchasing information. 7.4.3 Verification of purchased product: The manufacturer shall establish and implement the inspection or other activities necessary for ensuring that purchased product meets specified purchase requirements. Where the manufacturer intends to perform verification at the supplier's premises, the manufacturer shall state the intended verification arrangements and method of product release in the purchasing information. Records of the verification shall be maintained. 7.5 Production and service provision 7.5.1 Control of production and service provision: 7.5.1.1 General requirements The manufacturer shall plan and carry out production and service provision under controlled conditions. Controlled conditions shall include, as applicable:— (a) the availability of information that describes the characteristics of the product; (b) the availability of documented procedures, documented requirements, work instructions; and reference materials and reference measurement procedures as necessary; (c) the use of suitable equipment; (d) the availability and use of monitoring and measuring devices; (e) the implementation of monitoring and measurement; (f) the implementation of release, delivery and post-delivery activities; and Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India Page 149 of 248 (g) the implementation of defined operations for labeling and packaging.

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