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 deviations where (i) [*]
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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.

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

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

  • 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).

  • AM PeakOf the unsignalized intersections during the AM peak period in the recommended preferred alternative, one operated at LOS F.

  • 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.

  • Critical Deviation Report Sheet includes entries for planned cor- rective actions i.e. revisions of plan where necessaryFigure 5.

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

  • 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.


More Definitions of Critical Deviation

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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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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Related to Critical Deviation

  • Material Deviation refers to any contents or characteristics of the proposal that is significantly different from an essential aspect or requirement of the RFP, and : (i) substantially alters the scope and quality of the requirements; (ii) limits the rights of UNDP and/or the obligations of the offeror; and (iii) adversely impacts the fairness and principles of the procurement process, such as those that compromise the competitive position of other offerors.

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

  • Clinical Development means the conduct of clinical trials in humans to assess the dosing, safety and/or efficacy of the Product, including but not limited to Phase I Clinical Trials, Phase II Clinical Trials, Phase Ill Clinical Trials and Phase IV Clinical Trials.

  • 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

  • Critical areas means any of the following areas or ecosystems: wetlands, critical aquifer recharge areas, streams, fish and wildlife habitat conservation areas, frequently flooded areas, and geologically hazardous areas as defined by the Growth Management Act (RCW 36.070A.170).

  • 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 or “CI” means Diagnosis of any of the following Covered Conditions which occur directly as a result of illness, and first occur after the Effective Date of Insurance:

  • medical device means any instrument, apparatus, appliance, software, implant, reagent, material or other article intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the following specific medical purposes:

  • Critical habitat - means the following river reaches and their 100 year floodplains: the Gunnison River downstream of the Uncompahgre River confluence, the Colorado River downstream of the exit 90 north bridge from I-70, the White River downstream of Rio Blanco Dam, the Green River downstream of the Yampa River confluence, and the Yampa River downstream of the Colo 394 bridge.

  • 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.

  • Compliance Statement is that certain statement in the form attached hereto as Exhibit B.

  • Critical (C) means any equipment, medications or supplies critical for lifesaving patient care and which by its absence would jeopardize patient care.

  • 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.

  • 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.