MASTER BATCH RECORD (MBR definition
MASTER BATCH RECORD (MBR means the formal set of instructions for Production of Drug Product. The MBR shall be developed and maintained by the Parties in accordance with Section 4.3.
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Related to MASTER BATCH RECORD (MBR
Master Batch Record means the document, proposed by Lonza and approved by Customer, which defines the manufacturing methods, test methods and other procedures, directions and controls associated with the manufacture and testing of Product.
Batch Record means the production record pertaining to a Batch.
Batch means a specific quantity of Product that is intended to have uniform character and quality, within specified limits, and is produced according to a single manufacturing order during the same cycle of manufacture.
Quality Management Plan means the portion of the Project Development Plan providing the information requested in Section 4.3 of Exhibit B to the ITP.
Quality Management System means a set of interrelated or interacting elements that organisations use to direct and control how quality policies are implemented and quality objectives are achieved;