Validation/Qualification Sample Clauses

Validation/Qualification. 15.01 Determine according to Product lifecycle and guidance documents when process validation is required. X
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Validation/Qualification. 10.01 Have a written master validation/qualification plan for the facilities, equipment/instruments, manufacturing process, cleaning procedures, analytical procedures, in process control tests and computerized systems approved by the quality unit. X
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Validation/Qualification. Theravance and ScinoPharm agree to the following Validation/Qualification Policy for the Product:
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Validation/Qualification. 10.01 Have an appropriate written validation/qualification plan for the facilities, equipment/instruments, packaging process, cleaning procedures, analytical procedures, in process control tests and computerized systems approved by the quality unit. X
Sample 1
Validation/Qualification. Both parties agree to the following Validation/Qualification Policy. UCB representatives shall have the right to attend the manufacture of validation and launch batches. Equipment and facilities/utilities qualification/validation shall be performed for process, packaging, analytical methods, cleaning, and computerised systems. Process Validation shall consist of prospective performance on at least three consecutive production batches and must be conducted with commercial production/analytical processes and equipment. Manufacturer will not use any validation protocol or issue a report unless UCB have first approved such validation protocol or report. UCB will approve or reject all protocols and validation reports within fifteen (15) Business Days of receipt. Cleaning Validation shall involve three replicate runs of cleaning procedure for PRODUCT contact equipment during Process and Packaging Validation, except for dedicated equipment which will require one verification run of the cleaning procedure. The cleaning procedure and analytical methodology will be reviewed by both parties before the first Product Batches are manufactured. Revalidation shall be performed for significant changes to existing manufacturing processes, packaging, analysis, etc. (as determined by UCB). UCB shall have the right to required full or partial revalidation for changes made to the validated PRODUCT, based on a shared change control system and an assessment of the significance of the change. CONTRACT ACCEPTOR will notify UCB of any planned changes to a validated process or associated procedures sufficiently in advance to allow UCB an opportunity to assess the change(s) and any ramifications. No changes shall be made to the validated process or PRODUCT without prior written consent of UCB. The number of batches required for revalidation will be determined by UCB and CONTRACT ACCEPTOR based on the significance of the change.
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Validation/Qualification. 11.01 Define all process parameters, critical process control points and quality attributes and Specifications. [***] [***]
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Related to Validation/Qualification

  • Tax Qualification Each Employee Benefit Plan intended to be qualified under Section 401(a) of the Code has been determined to be so qualified by the Internal Revenue Service and nothing has occurred since the date of the last such determination which resulted or is likely to result in the revocation of such determination.

  • Organization; Qualification The Company is a corporation duly organized and validly existing under the laws of the State of Delaware and is in good standing under such laws. The Company has all requisite corporate power and authority to own, lease and operate its properties and assets, and to carry on its business as presently conducted. The Company is qualified to do business as a foreign corporation in each jurisdiction in which the ownership of its property or the nature of its business requires such qualification, except where failure to so qualify would not have a material adverse effect on the Company.

  • Foreign Qualification Prior to the Company’s conducting business in any jurisdiction other than Delaware, the Majority Members shall cause the Company to comply, to the extent procedures are available and those matters are reasonably within the control of the Majority Members, with all requirements necessary to qualify the Company as a foreign limited liability company in that jurisdiction.

  • FCC Qualifications Section 7.04

  • Foreign Qualifications Each of the Company and its subsidiaries is duly qualified as a foreign entity to transact business and is each in good standing in each jurisdiction in which such qualification is required, whether by reason of the ownership or leasing of property or the conduct of business, except where the failure to be so qualified would not singularly, or in the aggregate, in the reasonable judgment of the Company, be expected to result in a Material Adverse Effect.

  • Existence; Qualification The Borrowers will at all times preserve and keep in full force and effect their existence as a limited partnership, limited liability company, or corporation, as the case may be, and all rights and franchises material to its business, including their qualification to do business in each state where it is required by law to so qualify. Without limitation of the foregoing, each Borrower and, to the extent required by applicable law, General Partner and Member, shall at all times be qualified to do business in each of the states where the Properties are located.

  • Number; Qualification; Tenure (a) The number of Directors constituting the Board shall be at least three and no more than nine, and may be fixed from time to time pursuant to a resolution adopted by the Sole Member. Each Director shall be elected or approved by the Sole Member and shall continue in office until the removal of such Director in accordance with the provisions of this Agreement or until the earlier death or resignation of such Director.

  • Due Qualification The Servicer is duly qualified to do business as a foreign corporation, is in good standing and has obtained all necessary licenses and approvals, in all jurisdictions in which the ownership or lease of property or the conduct of its business (including the servicing of the Receivables as required by this Agreement) requires or shall require such qualification;

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