Critical Deviations definition

Critical Deviations shall have the meaning set forth in the Commercial Quality Agreement.
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Critical Deviations shall have the meaning set forth in Article 12(1).
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Critical Deviations indicate a significant risk that a Device could or would be harmful to a patient, or a deficiency which has produced a harmful Device, or a combination of major deficiencies which indicates a critical systems failure. For example: Cross-contamination, Mix-up, Wrong labeling (with Device safety impact)
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Examples of Critical Deviations in a sentence

  • For all Major Deviations and Critical Deviations, a complete and approved investigation report shall be sent to Radius upon completion of the investigation, within timing defined in the SOPs. ▇▇▇▇▇▇ Pharma and Radius shall separately agree on a process to facilitate agreement between the Parties on the investigation, the conclusion of the investigation and any corrective or preventive action required.

  • Major and Critical Deviations related to Manufacturing (including confirmed OOS and OOE) shall be provided by SANDOZ to Alder as a draft report for Alder review within [***] from the date of initial discovery.

  • KBI BioPharma will notify Client of any out of specification (OOS) results or other Critical Deviations within three (3) working days of confirming the OOS or observing the deviation.

  • Within [*] business days for Major Deviations and within [*] business days for Critical Deviations, from the time of discovery of such Deviation, ▇▇▇▇▇▇ Pharma shall provide Radius with a written report setting forth preliminary information on such Deviation.

  • Critical Deviations outside of OOS investigations will be investigated for root cause and fully documented by KBI BioPharma, targeting thirty (30) days after the date of discovery for completion.

  • BOPHELO will inform Cantourage about Deviations and Critical Deviations from the specified and agreed manufacturing and testing procedures, product specifications and batch results (OOS) with regard to the Medicinal Cannabis Materials in writing.