Master Batch Record

Master Batch Record. The document and its revisions, as mutually agreed by the Parties, that define the manufacturing methods, materials, and other procedures, directions and controls associated with the manufacture and testing of the API. Evonik shall manufacture each batch of API according to the processes set forth in the MBR. The MBR is written and controlled in compliance with regulations and guidance promulgated in the EU, Europe/ FDA, United States/ MHLW & PMDA, Japan. The MBR may also include or incorporate... by reference, without limitation, such information as material specifications, in process and final API sampling standards, equipment and instrumentation specifications and standard operating procedures, as set forth in the Quality Agreement for in-process quality control testing. View More

Master Batch Record. The formal set of instructions approved by the parties for production or manufacture of any Product.

Master Batch Record. Means, with respect to each Presentation of Product to be Produced hereunder, a formal set of instructions for the Production of each Presentation of such Product.