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 or “BPRs” means: the production records and control records and other supporting documents providing the manufacturing history of a Batch.

Batch Production Records means the records completed by Cytovance that document Cytovance’s steps and processes utilized in the manufacture of a CGMP Batch.

Examples of Batch Production Records in a sentence

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

• 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).

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

• 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.

• 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.

• Prepare and maintain the Batch Production Records and related control, distribution and other records required to comply with Specifications in all material respect.

• 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 Documentation to Customer in accordance with the terms of the Quality Agreement.

• 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.

• Each production lot from Sponsor is characterized by a full set of approved Batch Production Records (BPR).

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

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.

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.

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.”