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 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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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 Critical Deviation is defined as a departure from an approved process step, process condition, test requirement, or other relevant parameter or item that must be controlled within predetermined criteria to ensure that the final Product meets its specification or established standard and that has an adverse impact on the final Product quality and/or stability and/or physical characteristics.

  • 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.

  • If you would like for your documents or share certificate to be delivered to you by courier, or tracked delivery, please contact us and this can be arranged for an additional fee.

  • If this occurs, we would be left with inflated density figures while the mean number of connections for all network members remained low.

  • Critical Deviation A departure from an approved instruction or established standard that will have a direct impact on product quality.

  • 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.

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

  • Include Accreditation report showing compliance at or above the following expected minimum performance levels for at least the three months preceding the application: 7%Percentage of Deviation Accepted Critical Deviation Major Deviation Moderate Deviation Minor Deviation3% 3% 3% 3%b.

  • If a controller team commits a Critical Deviation the overall evaluation will continue to the end of the scenario if at all possible (evaluators will attempt to make adjustments in actions performed to aid in continuing the evaluation).7.7.2.7.2.5. Significant Deviations.


More Definitions of Critical Deviation

Critical Deviation means deviations where (i) [*]
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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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Related to Critical Deviation

  • Deviation is a departure from the requirements specified in the tendering document;

  • Critical Path means those Trade Contractor Work activities identified on the Construction Schedule which, if delayed, will cause a corresponding Delay in the Substantial Completion Date.

  • Critical area means an ISO Class 5 environment.

  • Adverse System Impact means a negative effect that compromises the safety or reliability of the electric distribution system or materially affects the quality of electric service provided by the electric distribution company (EDC) to other customers.

  • Project Operational Manual means the Project Operational Manual, to be adopted in accordance with Section 6.01 (a) of this Agreement, giving details of guidelines and procedures agreed with the Association for the implementation, supervision, and monitoring and evaluation, of the Project, and the procurement procedures and guidelines for Sub-Projects, as same may be amended from time to time in agreement with the Association, and such term includes any schedules to the Project Operational Manual;

  • Environmentally critical area means an area or feature which is of significant environmental value, including but not limited to: stream corridors, natural heritage priority sites, habitats of endangered or threatened species, large areas of contiguous open space or upland forest, steep slopes, and well head protection and groundwater recharge areas. Habitats of endangered or threatened species are identified using the Department’s Landscape Project as approved by the Department’s Endangered and Nongame Species Program.

  • Service Level Standards has the meaning ascribed thereto in Section 2.1 hereof.

  • major non-compliance outcome notification means a notification received by a council under section 19N(3) or (4) of the Food Act 1984, or advice given to council by an authorized officer under that Act, of a deficiency that does not pose an immediate serious threat to public health but may do so if no remedial action is taken

  • Compliance Review means an inspection of the home, grounds, and files to determine compliance with these regulations.

  • Quality Assurance means a systematic procedure for assessing the effectiveness, efficiency, and appropriateness of services.

  • Operational Manual means the manual referred to in Section 3.03 of this Agreement;

  • Web Site Accessibility Standards/Specifications means standards contained in Title 1 Texas Administrative Code Chapter 206.

  • Critical Illness means an illness, sickness or disease or corrective measure as specified in Section 6 of this policy document.

  • Operationally critical support ’ means supplies or services designated by the Government as critical for airlift, sealift, intermodal transportation services, or logistical support that is essential to the mobilization, deployment, or sustainment of the Armed Forces in a contingency operation.

  • Critical professional work means a cornerstone or fundamental decision, requiring the exercise of sound professional judgement of the effects of a decision within a particular professional field.

  • Clinical review criteria means the written screening procedures, decision abstracts, clinical protocols, and practice guidelines used by a health carrier to determine the necessity and appropriateness of health care services.

  • Drug utilization review means an evaluation of a prescription drug order and patient records for

  • Radiopharmaceutical quality assurance means, but is not limited to, the performance of appropriate chemical, biological, and physical tests on potential radiopharmaceuticals and the interpretation of the resulting data to determine their suitability for use in humans and animals, including internal test assessment, authentication of product history, and the keeping of proper records.

  • municipal spatial development framework means a municipal spatial development framework adopted by the Municipality in terms of Chapter 5 of the Municipal Systems Act;

  • Critical facility means a facility for which even a slight chance of flooding might be too great. Critical facilities include, but are not limited to, schools, nursing homes, hospitals, police, fire and emergency response installations, and installations which produce, use or store hazardous materials or hazardous waste.

  • Critical group means the group of individuals reasonably expected to receive the greatest exposure to residual radioactivity for any applicable set of circumstances.