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. (“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 is the collection of all manufacturing and control documentation regarding each single batch of the Product.
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Examples of Manufacturing Batch Record in a sentence

  • 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.

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

  • 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 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).

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

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

  • 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.

  • 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.

  • Lifecore shall document the Lot Numbers of all Raw Materials used to Manufacture a Batch of Product within the Manufacturing Batch Record.


More Definitions of Manufacturing Batch Record

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 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

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

  • Manufacturing Process means any process for—

  • 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.

  • 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 be of uniform character and quality, within specified limits, and is produced during the same cycle of Manufacture as defined by the applicable Batch Record.

  • 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

  • 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 all information, techniques, inventions, discoveries, improvements, practices, methods, knowledge, skill, experience and other technology, whether or not patentable or copyrightable, and any copyrights based thereon, relating to or necessary or useful for the production, purification, packaging, storage and transportation of Collaboration Products, including without limitation specifications, acceptance criteria, manufacturing batch records, standard operating procedures, engineering plans, installation, operation and process qualification protocols for equipment, validation records, master files submitted to the FDA, process validation reports, environmental monitoring processes, test data including pharmacological, toxicological and clinical test data, cost data and employee training materials.

  • 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, as applicable, current good manufacturing practices as described in:

  • 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, as set forth in this Agreement, required to manufacture Product or Products using the Active Materials, Components, and Xxxx Back Items;

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

  • SOPs means standard operating procedures.

  • 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 reasonably homogenous cannabis product in its final packaged form created using the same standard operating procedures and the same formulation.