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.
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 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;
Examples of Master Batch Record in a sentence
Cellares will retain possession of the Master Batch Record and Batch Records and will make copies of the Master Batch Record and Batch Records available to Partner.
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 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 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 the 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.
Master Batch Record or “MBR” means the Parties’ jointly approved manufacturing and control instructions for the Manufacture of a specific Batch.