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 Xxxxxx’x standard format by Baxter, using Celator’s master formula and technical support.
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.
Master Batch Record means, with respect to a Product, a master production and control record containing a written description of the procedure to be followed for processing a Batch of such Product, including a complete list of all active and inactive ingredients, components, weights and measures, descriptions of drug product containers, closures, packaging materials, and labeling and complete specifications for each, within the meaning of 21 CFR part 211.186, or its successor as in effect from time to time.
Examples of Master Batch Record in a sentence
Sxxxxxxxx shall conduct all Manufacturing Services in compliance with this Agreement, the Quality Agreement, the Master Batch Record, cGMP Regulations and all laws, rules and regulations applicable to the Manufacturing of the Product at the place of the Facility.
More Definitions of Master Batch Record
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 document containing the formula and procedures for the manufacturing and quality assurance of the Product, as such may be amended by the Parties in accordance with the terms hereof.
Master Batch Record means the document, proposed by Lonza and approved by Forty Seven, which defines the manufacturing methods, test methods and other procedures, directions and controls associated with the manufacture and testing of Product.
Master Batch Record means the master production instructions for manufacture of a Batch.
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.
Master Batch Record means the formal set of instructions for Processing of Product.
Master Batch Record means a document that defines the component required and quantities required for the manufacture of the Product and provide a step by step procedure for the manufacturing process being preformed.