Batch Production Records definition

Batch Production Records means the lot production records for the Batches manufactured by Bachem pursuant to this Agreement.
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Batch Production Records means the records completed by Cytovance that document Cytovance’s steps and processes utilized in the manufacture of a CGMP Batch.
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Batch Production Records or “BPRs” means: the production records and control records and other supporting documents providing the manufacturing history of a Batch.
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Examples of Batch Production Records in a sentence

  • The results of cell processing using the activated T cell process will be recorded on CRFs or in the Batch Production Records at the Johns Hopkins CTL facility.

  • A complete copy of all relevant and completed Batch Production Records for each manufacturing run of Compound, and all intermediates; which is set forth in documentation establishing the analytical methods contained in the Project, Validation Lot or Commercial Operation Plans (by inclusion or reference therein).

  • Agilent shall maintain records, including Master Batch Records and Batch Production Records, with respect to the manufacturing and quality testing of the Product and shall deliver the Executed Batch Record (in electronic PDF format) to Customer prior to Agilent providing the complete Batch Packet to Customer.

  • The dates of manufacture will be determined by, and documented in, the Batch Production Records.

  • At TMC's request, UCB shall provide access to Batch Production Records and any other documentation as requested by TMC to support regulatory approvals or compliance.

  • Batch Production Records are a compilation of master documents and records that contain the procedures and specifications for the Product.

  • Documentation used in production should include written instructions for producing batches of each material, given with sufficient detail that the operators can clearly follow these, and make the necessary records where required, (Batch Production Records).

  • Copies of redacted Batch Production Records shall be sent to MAP upon completion of its review by EDDI QA.

  • If the dispute concerns the CGMP Batch’s conformance to the Specifications or Cytovance’s adherence to the CGMP Manufacturing Process, the Parties will submit the Master Batch Records, Batch Production Records, Specifications, SOW, and other information relevant to the dispute (including a representative sample of the CGMP Batch, if necessary) to an independent testing laboratory mutually agreed to by the Parties.

  • Omeros may request additional documentation to support its review and release of Product lots, including but not limited to copies of Batch Production Records, testing results, raw data from Product testing and in-process test results.


More Definitions of Batch Production Records

Batch Production Records means the batch production records of ARIKACE, which document the Manufacture of the Batch according to the ARIKACE Specifications.
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Batch Production Records. (BPRs) means: completed written records providing the history of a Batch required to be kept by the European Guide to Good Manufacturing Practices for Medicinal Products, the U.S. Code of Federal Regulations, and ICH Guideline Q7A.
Sample 1
Batch Production Records or “BPRs” means: the production records and other supporting documents providing the manufacturing history of a Batch, as required under GMP. Batch Production Records or BPRs may also be referred to as “Manufacturing Procedures” or “MP.”
Sample 1

Related to Batch Production Records

  • 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.

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

  • Collection Records means all manually prepared or computer generated records relating to collection efforts or payment histories with respect to the Receivables.

  • API means 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.

  • 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.

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

  • Samples means physical examples which illustrate materials, equipment or workmanship and establish standards by which the Work will be judged.

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

  • Education records means an education record as defined in the Family Educational Rights and Privacy Act and its implementing regulations, 20 USC Section 1232g and 34 CFR Part 99, respectively.

  • Study Materials means all the materials and information created for the Study, or required to be submitted to the Sponsor including all data, results, Biological Samples, Case Report Forms (or their equivalent) in whatever form held, conclusions, discoveries, inventions, know-how and the like, whether patentable or not, relating to the Study, which are discovered or developed as a result of the Study, but excluding the Institution’s ordinary patient records.

  • Manufacturing Process means any process for—

  • 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.

  • 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.

  • Milk product or "dairy product" means cottage cheese, dry curd cottage cheese, reduced fat cottage cheese, lowfat cottage cheese, cream, light cream, light whipping cream, heavy cream, heavy whipping cream, whipped cream, whipped light cream, sour cream, acidified sour cream, cultured sour cream, half-and-half, sour half-and-half, acidified sour half-and-half, cultured sour half-and-half, reconstituted or recombined milk and milk products, concentrated milk, concentrated milk products, skim milk, lowfat milk, frozen milk concentrate, flavored milk, eggnog, buttermilk, cultured milk, cultured lowfat milk, cultured skim milk, yogurt, lowfat yogurt, nonfat yogurt, acidified milk, acidified lowfat milk, acidified skim milk, low-sodium milk, low-sodium lowfat milk, low-sodium skim milk, lactose-reduced milk, lactose-reduced lowfat milk, lactose-reduced skim milk, aseptically processed and packaged milk, milk products with added safe and suitable microbial organisms, and any other milk product made by the addition or subtraction of milkfat or addition of safe and suitable optional ingredients for protein, vitamin, or mineral fortification. Unless a product is considered a milk product under this subdivision, milk product does not include dietary products, infant formula, ice cream or other desserts, cheese, or butter. Milk products include the following:

  • Product Data are illustrations, standard schedules, performance charts, instructions, brochures, diagrams, and other information furnished by the Contractor to illustrate materials or equipment for some portion of the Work.

  • 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.

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

  • Program Materials means the documents and information provided by the Program Administrator specifying the qualifying EEMs, technology requirements, costs and other Program requirements, which include, without limitation, program guidelines and requirements, application forms and approval letters.

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

  • Study Data shall have the meaning set forth in Section 8.1.

  • Product Specification means the document referred to in:

  • Detailed manufacturing or process data means technical data that describe the steps, sequences, and conditions of manufacturing, processing or assembly used by the manufacturer to produce an item or component or to perform a process.

  • Contractor Materials means Materials owned or developed prior to the provision of the Work, or developed by Contractor independently from the provision of the Work and without use of the JBE Materials or Confidential Information.

  • 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 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;