Reprocessing and Rework. Patheon will not reprocess or rework the Product without the prior written consent from the Client. Reprocessing is defined as the introduction of material back into the process and repeating a step, (e.g. redrying, remilling) using the same equipment and techniques of the established manufacturing process. Rework is defined as the introduction of material to one or more processing steps that are different from the established manufacturing process.
Reprocessing and Rework. 17.1 AMGEN will not conduct any Reprocessing or Reworking of materials of Product without prior approval by COMPANY.
Reprocessing and Rework. 16.1 It is agreed between the parties that reprocessing shall be exceptional. Reprocessing of Additional Material or Bulk Product or Products must be fully documented to state reason and justification for reprocessing.
Reprocessing and Rework. Prior to DMF Approval, CPI will not reprocess or rework the Drug Resin Complex without the prior written consent from the Regulatory Consultant as submitted and approved in the ANDA. There will be no reprocessing and reworking of the Drug Resin Complex unless specifically defined in the DMF application that has been approved by the FDA. Reprocessing is defined as the introduction of material back into the process and repeating a step or steps not defined in the master batch records, (e.g. redrying, remilling) using the same equipment and techniques of the established manufacturing process. Rework is defined as the introduction of material to one or more processing steps that are different from the ANDA validated manufacturing process.
Reprocessing and Rework. Patheon will not reprocess or rework the Product without the prior written consent from Cangene.
Reprocessing and Rework. It is agreed between the parties that reprocessing and reworking shall be exceptional. Reprocessing and/or Rework of Material or Bulk Product or Products must be fully documented to state reason and justification for reprocessing and/or Rework. Rework activity can only be performed as per agreement between both UMAN and CLIENT.
Reprocessing and Rework. Reprocessing and/or Rework activity can only be performed by mutual agreement of the Parties. Reprocessing and/or Rework directions must be established to define the process for such Reprocessing and/or Rework. If the Product is a filed NDA or equivalent, Reprocessing and/or Rework parameters must be developed and approved by Tercica and CBSB prior to implementation. Reprocessing and/or Rework of Drug Substance must be documented to state rationale and justification.
Reprocessing and Rework. Reprocessing and Rework is not permitted for Product(s) covered in this Quality Agreement or the associated MSA.
Reprocessing and Rework. Reprocessing and rework activity can only be performed per mutual written agreement by AVID and HALOZYME. Reprocessing and rework directions must be established to define the process. If BDS has been filed as a drug substance in an NDA or equivalent, reprocessing parameters must be developed and submitted to the HALOZYME for regulatory submission, prior to approval. Reprocessing or rework of material or BDS must be documented to state reason and justification for reprocessing.
Reprocessing and Rework. Reprocessing or rework of the Product will only be performed following a mutually agreed upon plan. Routine issues that are identified and resolved during manufacturing and product testing will be documented in the Product’s Device History Record and will be approved by Nova Biomedical. All reworked material must meet final release requirements.
