Reprocessing and Reworking Sample Clauses
Reprocessing and Reworking. 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.
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. [*]
5.3.2 [*]
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.
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.
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.