Manufacturing Batch Record definition

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.
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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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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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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.

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

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

  • 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 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).

  • Details on study drug preparation by the PRA Health Sciences (PRA) pharmacy will be described in the Manufacturing Batch Record, which will be prepared by the PRA pharmacy.4.3.3 Investigational Medicinal Product AccountabilityAll IMPs required for completion of this study (balovaptan tablets and the [13C]-labeled balovaptan drug substance for IV infusion) will be provided by the Sponsor where required by local health authority regulations.

  • Cadence shall have the right to reject any shipment, if Cadence determines that (i) the Product does not conform to the Specifications or the Applicable Laws, or (ii) the related Manufacturing Batch Record does not demonstrate Product compliance with the cGMPs. Prior to any such return, Cadence shall request a return authorization from Grifols, which authorization shall not be unreasonably withheld or delayed, and the return of such Product shall be made in accordance with such authorization.


More Definitions of Manufacturing Batch Record

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.
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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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Related to Manufacturing Batch Record

  • Manufacturing Process means any process for—

  • Manufacturing site means the facilities where a Compound is Manufactured by or on behalf of a Party, as such Manufacturing Site may change from time to time in accordance with Section 8.7.

  • 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 the American Petroleum Institute.

  • cGMP means current Good Manufacturing Practices as specified in the United States Code of Federal Regulations, ICH Guideline Q7A, or equivalent laws, rules, or regulations of an applicable Regulatory Authority at the time of manufacture.

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

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

  • Product Specifications means those product, labeling and performance specifications for the Product filed with and approved by the relevant Regulatory Authority, including Product formulae, labeling, and materials required for the manufacture of the Product that is to be purchased and supplied under this Agreement, as such are set forth on Schedule 1.25, which specifications may be amended by the Parties from time to time in accordance with this Agreement.

  • 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.

  • 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 and stability testing, packaging and related services, as contemplated in this Agreement, required to produce 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 5.7(b).

  • 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.