Master Batch Record

Master Batch Record. The formal set of instructions for Production of Client Product. The MBR shall be developed and maintained in Althea's standard format by Althea, using Client's master formula and technical support.

Master Batch Record. The document, as may be amended from time to time, specifying: (i) the API and Excipient Specifications, (ii) the procedures for testing and releasing the API and Excipients, (iii) the Primary Components, (iv) Secondary Packaging, (v) the Product Specifications, (vi) the formula (listing the API and the Excipients for the Product), (vii) the procedures for manufacturing the Product (listing the API, the Excipients, the Primary Components, and the Secondary Packaging), and (viii) the procedures... for assuring the quality of the Product View More

Master Batch Record. A written description of the Manufacturing Process, reviewed and approved by ImmunoGen before Manufacturing commences, which shall include all technical requirements and Manufacturing parameters with regard to the Manufacturing methods.

Master Batch Record. The formal set of instructions for Production of Product, as amended, supplemented or restated from time to time by mutual written agreement of the parties. The MBR will be developed jointly by Halozyme and Baxter and approved by both parties, prior to Production of Product

Master Batch Record. A detailed, step-by-step description of the entire Manufacturing Process for the PRODUCT, which explains 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. The document approved and mutually executed in writing by both parties, and as may be amended from time to time in accordance with this Agreement and the Quality Agreement, specifying or referencing the complete set of formal instructions agreed upon by the Parties for the Production of Client Product, including material descriptions, the formula, processing procedures, and in-process testing Specifications, Specifications and Labeling and shipping Specifications.

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. The document and its revisions, as mutually agreed by the Parties, that define the manufacturing methods, materials, and other procedures, directions and controls associated with the manufacture and testing of the API. Evonik shall manufacture each batch of API according to the processes set forth in the MBR. The MBR is written and controlled in compliance with regulations and guidance promulgated in the EU, Europe/ FDA, United States/ MHLW & PMDA, Japan. The MBR may also include or incorporate... by reference, without limitation, such information as material specifications, in process and final API sampling standards, equipment and instrumentation specifications and standard operating procedures, as set forth in the Quality Agreement for in-process quality control testing. View More

Master Batch Record. The formal set of instructions approved by the parties for production or manufacture of any Product.