Batch Production Records definition

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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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 batch production records of ARIKACE, which document the Manufacture of the Batch according to the ARIKACE Specifications.
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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 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. (BPRs) means completed written records providing the history of a Batch of rhPTH 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.
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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.”
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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.

  • API means American Petroleum Institute.

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

  • 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.

  • 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:

  • Manufacturing Site means a location where a manufacturing

  • 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;

Most Referenced Clauses

Most Referenced Definitions