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 which defines the manufacturing methods, test methods and other procedures, directions and controls associated with the manufacture and testing of cGMP Batches.
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
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.
The Master Batch Record shall be reviewed and approved by ▇▇▇▇▇▇ and by Client in writing prior to commencement of Production.
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 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.
Master Batch Record means the formal set of instructions for Processing 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. ( or “MBR”) shall mean the formal set of instructions for Production of Client Product. The MBR shall be developed and maintained in Althea’s standard format by ▇▇▇▇▇▇, using Client’s master formula and technical support.
Master Batch Record or “MBR” means the Parties’ jointly approved manufacturing and control instructions for the Manufacture of a specific Batch.