Manufacturing Batch Record definition

Manufacturing Batch Record. (“MBR”) or “Batch Production Record” (“BPR”)) means a Manufacturing record for a Batch generated by PROVIDER concurrently with the production of a specific Batch such that successive steps in such processes, including methods, are documented.
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Manufacturing Batch Record means a detailed, step-by-step description of the entire production process for a specific drug. The Manufacturing Batch Record (“MBR") explains exactly how the product is produced, indicating specific types and quantities of components and raw materials, processing parameters, in-process quality controls, environmental controls, etc. An executed Batch Record documents the production events, quality charts, environmental monitoring records and inspection reports for the entire production process for a specific batch.
Sample 1
Manufacturing Batch Record. A Manufacturing Batch Record (MBR) is a detailed, step- by-step description of the entire production process for a specific drug. The MBR explains exactly how the product is produced, indicating specific types and quantities of components and raw materials, processing parameters, in-process quality controls, environmental controls, etc. An executed MBR documents the production events, quality charts, environmental monitoring records and inspection reports for the entire production process for a specific batch.
Sample 1

Examples of Manufacturing Batch Record in a sentence

  • The Manufacturing Batch Record includes information on the equipment, raw materials used during the process, each operator signature and initials and, when applicable, the verifier initials at critical steps in the process, the accountability of the Product and any Deviations from the approved procedure.

  • GENETHON will maintain accurate batch records (Manufacturing Batch Record and QC file) of the Product, as required by applicable laws and regulations in sufficient detail and in accordance with GMP conditions, to properly reflect all work performed and results obtained.

  • The original, approved template used for the execution of each Manufacturing Batch Record.

  • The original, approved Manufacturing Batch Record that serves as the template to be completed for each production run is the Master Batch Record.

  • GENETHON will retain possession of the industrial documentation linked to the production of the Product (SOPs, analytical specifications, Manufacturing Batch Record, QC file - including Certificate of Analysis).

  • The full analytical testing results including in process control and final product QC results will be part of the Manufacturing Batch Record available for review on site GENSIGHT.

  • GENETHON’s facilities, equipment, QC and QA system operating procedures shall be used unless otherwise specified in the Manufacturing Batch Record.

  • The main document language is English except for the Master Batch Record, Manufacturing Batch Record, processing instructions and SOPs.

  • SIEGFRIED shall provide CELGENE with accurate copies of each Manufacturing Batch Record .

  • All such labeling and packaging shall be in accordance with the Manufacturing Batch Record and applicable Product Specifications.


More Definitions of Manufacturing Batch Record

Manufacturing Batch Record is the collection of all manufacturing and control documentation regarding each single batch of the Product.
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Manufacturing Batch Record means documentation of the manufacturing, process, packing, and holding of specific lot of drug active ingredient.
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Manufacturing Batch Record or its acronym “BMR” means all documents associated with the manufacture of a batch of bulk product or finished medicinal product;
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Related to Manufacturing Batch Record

  • Batch Record means the production record pertaining to a Batch.

  • Manufacturing Process means any process for—

  • 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.

  • Manufacturing Site means a location where a manufacturing

  • Batch means a specific quantity of Product that is intended to have uniform character and quality, within specified limits, and is produced according to a single manufacturing order during the same cycle of manufacture.

  • API means American Petroleum Institute.

  • cGMP means current Good Manufacturing Practice as set forth in the United States Federal Food, Drug, and Cosmetic Act, as amended, and includes all rules and regulations promulgated by the FDA thereunder.

  • Bulk drug substance means any substance that is represented for use, and that, when used in the

  • Drug Substance means an active ingredient that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure or any function of the human body, but does not include intermediates used in the synthesis of such ingredient.

  • Product Specification means a product specification for a Medical Device set out in Schedule 2;

  • Product Specifications means the specifications, features and/or terms of any "Contract" (as defined in the LME Rules) listed for trading on the LME, as described in the LME Rules;

  • Manufacturing Facility means buildings and structures, including machinery and equipment, the primary purpose of which is or will be the manufacture of tangible goods or materials or the processing of such goods or materials by physical or chemical change.

  • Bulk Product means Licensed Product supplied in a form other than Finished Product which can be converted into Finished Product.

  • Manufacturing Know-How means, with respect to the Product or any Variant thereof, the technology, data, designs, processes, methods, specifications and other know-how used in connection with the formulation, manufacture, labeling, packaging, quality control, release testing, and production of the Product, and all ingredients used therein and portions thereof.

  • Manufacturing operation means a process in which materials are changed, converted, or transformed into a different state or form from which they previously existed and includes refining materials, assembling parts, and preparing raw materials and parts by mixing, measuring, blending, or otherwise committing such materials or parts to the manufacturing process. "Manufacturing operation" does not include packaging.

  • Finished Product means a cannabis product in its final form to be sold at a retail premises.

  • GMP means the amount proposed by Contractor and accepted by Owner as the maximum cost to Owner for construction of the Project in accordance with this Agreement. The GMP includes Contractor’s Construction Phase Fee, the General Conditions Cost, the Cost of the Work, and Contractor’s Contingency amount.

  • Quality Agreement has the meaning set forth in Section 9.6.

  • cGMPs means current good manufacturing practices as described in Parts 210 and 211 of Title 21 of the United States’ Code of Federal Regulations, together with the latest FDA guidance documents pertaining to manufacturing and quality control practice, all as updated, amended and revised from time to time;

  • Drug sample means a unit of a prescription drug that is not intended to be sold and is intended to promote the sale of the drug.

  • Manufacturing Services means the manufacturing, quality control, quality assurance, stability testing, packaging, and related services, set forth in this Agreement, required to manufacture Product or Products from Active Materials and Components;

  • Drug Product means a specific drug in dosage form from a known source of manufacture, whether

  • SOPs has the meaning set forth in Section 3.7.

  • medicinal product means any substance or combination of substances presented for treating or preventing disease in human beings or animals and any substance or combination of substances which may be administered to human beings or animals with a view to making a medical diagnosis or to restoring, correcting or modifying physiological functions in humans or in animals;

  • MSAA Indicator Technical Specifications document means, as the context requires, either or both of the document entitled “Multi-Sector Service Accountability Agreement (MSAA) 2019-20 Indicator Technical Specifications November 5, 2018 Version 1.3” and the document entitled “Multi-Sector Service Accountability Agreement (MSAA) 2019-20 Target and Corridor-Setting Guidelines” as they may be amended or replaced from time to time;

  • Final Product means a product that is not used in producing other products and is built and intended for use outdoors, provided the final product has not deteriorated or has otherwise become a potential source of contaminants.