Production and Process Controls Sample Clauses

Production and Process Controls. Flextronics shall develop, conduct, control and monitor product processes to ensure that the Product(s) conform to the Specifications and were produced in substantial compliance with the QSR and ISO 13485.
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Production and Process Controls. Supplying Party shall develop, conduct, control, validate (where process results cannot be fully verified by inspection and testing) in accordance with 21 CFR 820.75 (Process Validation) and 820.70 (g) (Equipment Qualification) and conduct a documented risk analysis for the complete process of manufacturing (such as Process Failure Modes and Effects Analysis (“pFMEA”) or Control Plans, and monitor production processes to ensure that the Product conforms to Product Specifications.
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Production and Process Controls. 11.1 Maintain limited and controlled access to the Facility. X
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Production and Process Controls. Supplier shall develop, conduct, control and monitor production processes to ensure that the Product conforms to Specifications. Supplier shall assure that production equipment and quality measurement equipment, including mechanical, electronic, automated, chemical or other equipment, are: (i) suitable for the intended use; (ii) capable of producing valid results; (iii) operated by trained personnel; and, (iv) properly calibrated to the appropriate and suitable standard. If the output of a Supplier’s process is not fully verified by subsequent inspection or test, the Supplier shall validate the process. The Supplier shall create a validation protocol (describing the planned activities) and a validation report (documenting the outcome of the planned activities). A change or a deviation from a validated process shall be reviewed and if appropriate revalidated. Supplier shall keep records of the validation and revalidated activities and make them available to CCI upon request. If requested by CCI, Supplier shall create and maintain a process map, process failure modes and effects analysis (pFMEA), and process control plans for all steps from receiving through shipping.
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Production and Process Controls. Xxxxxxxxx-Xxxxx shall generate the master batch production record, labeling and packaging procedures for the Manufacture of the Product based on the information supplied by Auxilium. The master batch production record(s) and subsequent revisions shall be subject to the approval of Xxxxxxxxx-Xxxxx and Auxilium, and will contain a summary of any change(s) with appropriate justification(s) for change(s). Each batch shall be Manufactured in accordance with a batch production record, which is a uniquely identified copy of the master batch production record.
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Production and Process Controls. Xxxxxxxxx-Xxxxx shall generate the master batch production record, labeling and packaging procedures for the Manufacture of the Product based on the information supplied by Dyax. Both Dyax and Xxxxxxxxx-Xxxxx must approve the master batch production record. Each batch shall be Manufactured in accordance with a batch production record, which is a uniquely identified copy of the master batch production record.
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Production and Process Controls. Supplier shall establish procedures to develop, conduct, monitor, control, validate processes (where process results cannot be fully verified by subsequent inspection and testing) and qualify equipment. Validation activities, process changes and deviations shall be documented. Supplier shall establish and maintain procedures for monitoring and control of production processes to ensure that the Product conforms to Product Requirements, i.e. ISO 13485 7.1 (Planning of Product Realization). The monitoring and control methods, data, date performed, individual(s) performing the process and the major equipment used shall be documented.
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Production and Process Controls. 13.1. Insulet will maintain written procedures for production and process control of the Customized Insulet Device. Insulet will sterilize the Customized Insulet Device in accordance with the Insulet Product Definition Document INSPR020-PDD, Amgen Delivery Device ADD specifications. Sterilization results will be provided on the Certificate of Conformance.
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