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2023-05-26T05:31:03
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Status identificationThe manufacturer shall identify the product status with respect to monitoring and measu

Status identification The manufacturer shall identify the product status with respect to monitoring and measurement requirements. The identification of Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India Page 152 of 248 product status shall be maintained throughout production, storage, implant, usage and installation of the product to ensure that only product that has passed the required inspections and tests (or released under an authorized concession) is despatched, used or installed. 7.5.4 Customer property: The manufacturer shall exercise care with customer property while it is under the manufacturer's control or being used by the manufacturer. The manufacturer shall identify, verify, protect and safeguard customer property provided for use or incorporation into the product. If any customer property is lost, damaged or otherwise found to be unsuitable for use, this shall be reported to the customer and records maintained. Note: Customer property can include intellectual property or confidential health information. 7.5.5 Preservation of product: The manufacturer shall establish documented procedures or documented work instructions for preserving the conformity of product during internal processing and delivery to the intended destination. This preservation shall include identification, handling, packaging, storage and protection. Preservation shall also apply to the constituent parts of a product. The manufacturer shall establish documented procedures or documented work instructions for the control of product with a limited shelf-life or requiring special storage conditions. Such special storage conditions shall be controlled and recorded. 7.6 Control of monitoring and measuring devices The manufacturer shall determine the monitoring and measurement to be undertaken and the monitoring and measuring devices needed to provide evidence of conformity of product to determined requirements. The manufacturer shall establish documented procedures to ensure that monitoring and measurement can be carried out and are carried out in a manner that is consistent with the monitoring and measurement requirements. Central Drugs Standard Control Organization, Ministry of Health and Family Welfare, Govt. of India Page 153 of 248 Where necessary to ensure valid results, measuring equipment shall be:— (a) calibrated or verified at specified intervals, or prior to use, against measurement standards traceable to Bureau of Indian Standards wherever available; where no such standards exist, the basis used for calibration or verification shall be recorded; (b) adjusted or re-adjusted as necessary; (c) identified to enable the calibration status to be determined; (d) safeguarded from adjustments that would invalidate the measurement result; (e) protected from damage and deterioration during handling, maintenance and storage.

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