Critical Deviation definition

Critical Deviation means a departure from an approved instruction or established standard that will affect the safety, identity, strength, purity and/or quality of a PRODUCT.
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Critical Deviation means a deviation comprising any GSK Research Program conduct and when the validity and/or integrity of Study Related Data are affected, which may render the Study Related Data, a regulated Study, submission or facility invalid.
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Critical Deviation means a deviation that is likely to result in a hazardous or unsafe condition for individuals using the Product. A Critical Deviation affects the quality, strength, purity, identity, and/or integrity of the Lot.
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Examples of Critical Deviation in a sentence

  • Cardinal Health reserves the right to expend up to […***…] per Critical Deviation (as defined in the Quality Agreement) to complete all required investigational work (such as OOS investigations, trouble shooting chromatographic methods, etc.) without prior approval from the Xencor.

  • A document describing in detail the Major Alert and/or Critical Deviation shall be made available to GSK upon completion of the investigation.

  • The Client will review the completed Critical Deviation report and communicate to KBI BioPharma the result of its review, within five (5) business days.

  • If a Deviation should occur or becomes necessary which, after investigation by ▇▇▇▇▇▇ Pharma, will likely be categorized or recategorized as a Critical Deviation, ▇▇▇▇▇▇ Pharma shall notify Radius within [*] business day from the time of discoveryof or categorization as a Critical Deviation.

  • Alder will respond in writing [***] with comments related to the major or Critical Deviation or that the deviation is acceptable as written.

  • Upon the occurrence of a Major Deviation or a Critical Deviation, Ascendis shall have the final responsibility to determine the significance of the impact of said Deviation on the Product, including the further disposition of the affected Product.

  • Upon the occurrence of a Major Deviation or Critical Deviation, Radius shall have the final responsibility to determine the significance of the impact of said Deviation on the Product, including the further disposition of the affected Product.

  • If a Deviation should occur or become necessary which, after investigation by ▇▇▇▇▇▇ Pharma, is likely to be categorized as a Major Deviation or a Critical Deviation (including OOS), ▇▇▇▇▇▇ Pharma shall, within [***] from the time of discovery of either thereof, provide Ascendis with a written report setting forth preliminary information on such Deviation.


More Definitions of Critical Deviation

Critical Deviation means deviations where (i) [*]
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Critical Deviation means any departure that (i) impacts the regulatory commitments and/or reporting requirements of the Intermediate; (ii) requires re-qualification of methods, process or reference standards (where already qualified); and (iii) results in changing or modifying the specifications or methods.
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