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. 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.
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.
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.
Qualification and Validation. The following qualification and validation activities are included in the Base Fee, and only relates to the 20ml vial.
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.
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.
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