Reprocessing and Reworking Sample Clauses

Reprocessing and Reworking. 4.4.2.1. If either Ophthotech or Agilent determines that reprocessing or reworking of the GMP API is necessary due to OOS, manufacturing deviation, unmet Specifications, or otherwise, the procedure will be documented and approved by Agilent Chemical Development, Agilent Manufacturing, Agilent QA and Ophthotech QA, provided that Agilent shall not reprocess or rework the GMP API without the prior written consent of Ophthotech.
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Reprocessing and Reworking. 5.3.1 Prior to any Product batch being reprocessed or reworked, SurModics must obtain approval of the GNE Quality Unit in advance. Reprocessing and reworking are considered Significant Deviations and shall be handled in accordance to Section 7.2. [*]
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Reprocessing and Reworking. If requested by , a reprocessing procedure is permitted according to ICH Guidelines , Chapter 14.2 and any other applicable local regulation. Reworking must be performed, if at all, according to the SUBSTANCE (s) registration documents, if it is part of the dossier, or according to ICH Q7, chapter 14.3 and any other applicable local regulation. CMS should be informed of such batches/lots.
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Reprocessing and Reworking. Reprocessing or reworking of the API or any other intermediates in the GMP stages of the manufacturing process is not allowed under this Quality Agreement.
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Reprocessing and Reworking. A. CELGENE will work with SIEGFRIED to support any reprocessing and reworking procedures as allowed by cGMP, and to support any required filing(s), if required. Product will not be reworked without prior notification to CELGENE.
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Related to Reprocessing and Reworking

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  • Processing (a) The filing or pendency of any grievance or arbitration proceedings under this Article shall not operate to impede, preclude, or delay the University from taking the action complained of. Reasonable efforts, including the shortening of time limits when practical, shall be made to conclude the processing of a grievance prior to the expiration of the grievant's employment, whether by termination or failure to reappoint. An employee with a pending grievance will not continue to be compensated beyond the last date of employment.

  • Contract Management To ensure full performance of the Contract and compliance with applicable law, the System Agency may take actions including:

  • Metering The Interconnection Customer shall be responsible for the Connecting Transmission Owner’s reasonable and necessary cost for the purchase, installation, operation, maintenance, testing, repair, and replacement of metering and data acquisition equipment specified in Attachments 2 and 3 of this Agreement. The Interconnection Customer’s metering (and data acquisition, as required) equipment shall conform to applicable industry rules and Operating Requirements.

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