Qualification and Validation Sample Clauses

The Qualification and Validation clause establishes requirements for ensuring that equipment, systems, or processes meet predefined standards and function as intended. In practice, this clause typically mandates documented testing, inspections, or assessments before use, such as verifying that manufacturing equipment operates within specified parameters or that software systems perform reliably. Its core function is to ensure quality and compliance, reducing the risk of failures or defects by confirming that all critical components are properly vetted before being put into operation.
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Qualification and Validation a. AVECIA will perform appropriate installation qualification (IQ), operational qualification (OQ), and/or performance qualification (PQ) for the required classes of equipment used and process used for the production and control of AGU. Evaluation and/or re-validation will be conducted in accordance with appropriate specifications/ procedures. X Confirm in audit b. Documentation of such activities and/or schedule of revalidation shall be the responsibility of AVECIA. X Confirm in audit c. Documentation shall be available to DYNAVAX or partners, upon mutual agreement with AVECIA, or Regulatory Authorities upon request. X
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Qualification and Validation. LONZA shall be responsible for validating the LONZA Equipment used for supply of Product or, if applicable, performance of the Services (including conducting installation, operational and performance qualification), and the production, cleaning and, to the extent applicable, packaging processes, as well as all other appropriate steps performed at the Facilities. All activities and procedures must: (i) meet applicable regulatory requirements; and (ii) be found acceptable by Regulatory Authority inspectors, if applicable. If any Regulatory Authority finds LONZA’s validation procedures to be unacceptable, then LONZA will take (or have taken) appropriate remedial measures, including repeating the validation as necessary, such that the validation procedures meet all applicable regulatory requirements and guidelines, including those necessary to receive all Regulatory Authority approvals. If any of LONZA’s validation procedures fail to comply with cGMP or the Specifications, LONZA shall promptly remedy such failure in order to comply with all cGMP and Specifications. Furthermore, LONZA shall also be responsible for validating the MODERNA Equipment under the terms set forth above when agreed upon in the relevant Statement of Work.
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Qualification and Validation. Agilent will be responsible for the qualification and validation of manufacturing and testing equipment and processes, as mutually defined by Agilent and Ophthotech.
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Qualification and Validation. The ACCEPTOR agrees that the distribution system used must be validated. Furthermore, the documentation as laid down in the specifications shall be followed, using calibrated and qualified equipment, computer systems and machines.
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Qualification and Validation. NOVARTIS agrees that manufacturing, in-process and quality control, and cleaning procedures must be validated and carried out under cGMP rules. Furthermore, the manufacturing instructions shall be followed using calibrated and qualified equipment, computer systems and machines.
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Qualification and Validation. Qualification and validation consist of pre-defined and pre-approved protocols to assess the defined parameters of a specified test procedure, or production method. Qualification provides documented data that assesses the suitability of a specified test procedure, or production method for its intended purpose, and validation provides documented evidence that a test procedure, or production method is suitable (within pre-defined parameters) for its intended purpose. Validation reports are the output of an executed validation protocol.
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Qualification and Validation. The following qualification and validation activities are included in the Base Fee, and only relates to the 20ml vial.
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Related to Qualification and Validation

  • Qualification and Good Standing Each Loan Party is qualified to do business and in good standing in every jurisdiction where its assets are located and wherever necessary to carry out its business and operations, except in jurisdictions where the failure to be so qualified or in good standing has not had and will not have a Material Adverse Effect.

  • Qualifications of Panelists All Panelists shall: (a) have expertise or experience in law, international trade, other matters covered by this Agreement, or the resolution of disputes arising under international trade agreements relevant to the subject matter of the dispute; (b) be chosen strictly on the basis of objectivity, impartiality, reliability, and sound judgment; (c) be independent of, and not be affiliated with or take instructions from, any Party; (d) not delegate their responsibilities to any other person; and (e) comply with the Model Rules of Procedure established in Annex 12 (Model Rules of Procedure).

  • QUALIFICATION OF BIDDERS BID PACKAGE REQUIREMENTS:

  • Election and Term of Office The officers of the Company shall be elected from time to time by the Board. Each officer shall hold office until such person’s successor shall have been duly elected and qualified or until such person’s death or until he or she shall resign or be removed pursuant to Section 8.9.

  • STAFF QUALIFICATIONS a) CONTRACTOR shall ensure that all individuals employed, contracted, and/or otherwise hired by CONTRACTOR to provide classroom and/or individualized instruction or related services hold a license, certificate, permit, or other document equivalent to that which staff in a public school are required to hold in the service rendered consistent with Education Code section 56366.1(n)(1) and are qualified pursuant to Title 5 of the California Code of Regulations sections 3064 and 3065. b) Only those NPS/A located outside of California that employ staff that hold a current valid credential or license to render special education and related services as required by that state shall be eligible to be certified. NPA/NPS staff shall be required to hold credentials and licenses within the state where they are providing services regardless of where the agency is located. c) When CONTRACTOR is a nonpublic school, NPS, an appropriately qualified person shall serve as curricular and instructional leader, and be able to provide leadership, oversight and professional development. The administrator of the NPS holds or is in the process of obtaining one of the following: (A) An administrative credential granted by an accredited postsecondary educational institution and two years of experience with pupils with disabilities.