Master Batch Records definition

Master Batch Records means the master batch records for Arena’s (or its designee’s) manufacturing of a specific Finished Product, as established in accordance with the Quality Agreement, including the applicable Manufacturing SOPs, the in-process testing and QA/QC testing for such Finished Product, which records are to be used in the manufacture by or on behalf of Arena of such Finished Product for supply to Eisai under Article 6.

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Master Batch Records means, for a given Drug Product, the then-current procedures to be followed by Patheon with respect to the Processing, handling and storage of that Drug Product and the corresponding API, as contemplated in Exhibits A and B of the Product-Specific Appendix for that Drug Product.

Master Batch Records means the record determining the Process by which a Batch is manufactured, as required under GMP.

Examples of Master Batch Records in a sentence

Subject to Section 2.8, as agreed between the Parties pursuant to the Quality Agreement, Emergent shall maintain the Master Batch Records related to the Manufacturing of Products under this Agreement.
Emergent shall prepare and maintain the Master Batch Records for the Manufacturing of Products at the Manufacturing Facility.
If Artiva elects to Manufacture Product itself; or to have Product Manufactured by a third party, Manufacturer will provide to Artiva, or its designee, all Manufacturing information, including, without limitation, Records, copy of the Master Batch Records, SOPs, documentation, technical assistance, materials and cooperation by appropriate employees of Manufacturer as Artiva or its designee may reasonably require in order to Manufacture Product.
If any such Services include a technical process transfer or the production of specific deliverables (including, without limitation, engineering or validation Batches of Product, reports, Master Batch Records, Batch Documentation, and analytical results), the specifications of such technical process transfer or deliverables shall be set forth on the relevant Work Order.
INTRABIOTICS reserves the right to review and approve the Master Batch Records prior to their use in the production of intermediates or bulk drug substance.

More Definitions of Master Batch Records

Master Batch Records means the master batch records for Arena’s (or its designee’s) manufacturing of a specific Product, as established in accordance with the applicable Quality Agreement, including the applicable Manufacturing SOPs, the in-process testing and QA/QC testing for such Product, which records are to be used in the manufacture by or on behalf of Arena of such Product for supply to Eisai under this Agreement.

Master Batch Records means the electronic or paper template document approved in writing by both parties that contains the complete set of formal instructions for the Manufacture of Clinical Material to be used by Biocon hereunder (including the applicable Manufacturing SOPs, descriptions of Materials, the Manufacturing Process, in-process testing specifications, Specifications and packaging, storage and shipping specifications) and meets the requirements of GMP, as such document may be amended from time to time in accordance with the Quality Agreement.

Master Batch Records mean the approved formulation, manufacturing/packaging instructions, and controls whereby a Batch of Product is manufactured. Master Batch Records must be written per cGMPs for all clinical, registration, stability, and commercial manufacturing processes and may be issued repeatedly of the manufacture of the same Batch of Product.

Master Batch Records. (or “MBRs”) shall mean the written descriptions of the Manufacturing Process used hereunder for each Product, which shall include the technical requirements and specifications with regard to the manufacturing methods, packaging process, and storage methods and procedures, as applicable, and as further clarified, and subject to, Section 1 of Appendix 4.

Master Batch Records means the Client-approved, step-by-step description of the entire Manufacturing Process and all necessary production tasks and activities for the manufacture of a CGMP Batch and the MCB.

Master Batch Records means the master batch records prepared by BLP in accordance with CGMP requirements which now or hereafter govern the Processing of Drug Substance into Drug Product.

Master Batch Records means the approved instructions for the manufacture of a lot of DRUG PRODUCT.

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