Common use of Reprocessing and Rework Clause in Contracts

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.