Master Batch Record definition

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.

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Master Batch Record means the complete detailed Manufacturing and control instructions and specifications for the Manufacturing Process for the Product, as defined by the applicable validation protocol and cGMP Requirements, as may be amended from time to time; in accordance with cGMP Requirements, or by mutual agreement of both Customer and Supplier;

Master Batch Record means the document that defines the manufacturing methods, materials, and other procedures, directions and controls associated with the manufacture and testing of the Product, which may be amended in writing from time to time by mutual agreement of the Parties.

Examples of Master Batch Record in a sentence

Prior to the commencement date of Services in a SOW, Customer, at its sole expense, shall cause to be delivered to the Emergent Facility the following items: (a) the quantity of Customer Supplied Items as necessary to perform the Services identified in a given Purchase Order; (b) if required by the Quality Agreement, a Certificate of Analysis for the Customer Supplied Items; (c) a Safety Data Sheet for the Customer Supplied Items and the Product; and (d) a signed Master Batch Record, if applicable.
Unless specifically agreed to otherwise by the Parties in writing, Emergent will be responsible for the procurement, at Customer’s sole expense, of any Materials (other than Customer Supplied Items) as agreed upon and as detailed in the Master Batch Record, insofar as required to permit Emergent to complete the Manufacturing and delivery of Product in accordance with the terms of this Agreement.

More Definitions of Master Batch Record

Master Batch Record or “MBR” shall mean, with respect to each Presentation of Clinical Product or Commercial Product to be Produced hereunder, a formal set of instructions for the Production of each Presentation of such Product. The MBR shall be developed and maintained in ▇▇▇▇▇▇’▇ standard format by Baxter, using Celator’s master formula and technical support.

Master Batch Record or “MBR” means the document containing the mutually agreed to Manufacturing Process including but not limited to the instructions for formulation, filling, lyophilization if applicable, packaging, labeling and specifications for components and raw materials to be used in the Manufacture of the Product. In-process and finished Product Specifications for the Product will be referenced in the Master Batch Record. It may also be referred to as the “Master Production Record” or “MPR”. The MBR may be amended from time to time by mutual written agreement of the Parties

Master Batch Record means the master production instructions for manufacture of a Batch.

Master Batch Record or “MBR” shall mean, with respect to each Product to be Manufactured hereunder, a formal set of instructions given by Seres for the Manufacture of each such Product. The MBR shall be developed and maintained in GenIbet’s standard format by GenIbet, as per Seres’ instructions and using master formulation and technical support.

Master Batch Record means a detailed, step-by-step description of the entire Manufacturing Process for a specific Product, which explains exactly how the product is Manufactured, indicating specific types and quantities of components and raw materials, Additional Materials, processing parameters, in-process quality controls, and other relevant controls.

Master Batch Record means the formal set of instructions for Processing of Product.