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 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.

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.

Examples of Master Batch Records in a sentence

• 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.

• 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.

• However, in cases where there are substantial grounds for a review of the grade and a resolution cannot be reached between the student and the instructor, the student has the following recourse:1.

• Any change to the Master Batch Records requires prior written approval by BI Pharma.

• All Drug Product supplied to BI Pharma hereunder (i) will comply with all applicable Draft Specifications or Final Specifications at the time of manufacture and (ii) will have been manufactured in accordance with the Master Batch Records and cGMP.

More Definitions of Master Batch Records

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

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 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 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 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. (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 batch records for Arena’s (or its designee’s) manufacturing of a specific Finished Product or Compound, 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 or such Compound, which records are to be used in (a) the manufacture by or on behalf of Arena of such Finished Product pursuant to this Agreement or (b) the manufacture by or on behalf of Arena of such Compound for use in the manufacture of Finished Product pursuant to this Agreement.