Master Batch Records

Master Batch Records. Means the document that contains the instructions for manufacturing the Product, and the related Product Specifications. Prior to the initiation of the first CGMP manufacturing run, the Master Batch Record shall be approved by CLIENT in writing. CLIENT's written approval of the Master Batch Record is also an acknowledgement that CLIENT adopts the Master Batch Record as its own specification in accordance with Section 6.7 of this agreement. Any changes or additions to the Master Batch Record... after initial approval by CLIENT shall be made by the written agreement of COOK and CLIENT. View More

Master Batch Records. Means the Client-approved, step-by-step description of the entire Manufacturing Process and all necessary production tasks and activities for the manufacture of a CGMP Batch and the MCB.