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 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, 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

Each copy of the Master Batch Record for such Batch of Client Product shall be assigned a unique Batch number.
Each Batch of Client Product shall be Produced by using a copy of the Master Batch Record.
Any deviation from the manufacturing process specified in the Master Batch Record must be documented in the copy of the Master Batch Record for that Batch.
Any deviation from the Production Process specified in the Master Batch Record must be documented in the copy of the Master Batch Record for that Batch.
In addition, Hospira will provide Theravance with a copy of the Master Batch Record and all other documents and records as required by the Quality Agreement for Theravance’s release of the batch and such samples of the batch that Theravance may reasonably request.

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 formal set of instructions for the Manufacture of any 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 instructions for the Manufacturing Process for the Product, as defined by the 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 master production and control records required by the FDA to be kept for the Product pursuant to 21 CFR Section 211.186.

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