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.

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 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.

• Xxxxxx shall notify Client of and require written approval from Client for changes to Master Batch Records and Client Product Specifications prior to the Production of subsequent Batches of Client Product.

• 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.

• 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.

More Definitions of Master Batch Records

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 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 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.

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 master or unexecuted batch records for Product as established by mutual written agreement of the parties, including the applicable Manufacturing SOPs, the in-process testing and QA/QC testing for such Product, which are to be used in the manufacture and testing of Product by Novasep hereunder.

Master Batch Records means a detailed, step-by-step description of the entire production process for the Product, including an explanation of the Product is produced and indicating, among other things, specific types and quantities of components and Raw Materials, processing parameters, in-process quality controls.