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, 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
In 2004, through Dutch funding, the programme placed at the centre of its strategy the development of SES indicators database, and PSS and ELFS.
ImmunoGen will provide BI Pharma with Master Batch Records describing the Manufacturing Process for Drug Product as well as for Drug Substance.
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.
The Master Batch Records will be agreed upon by the Parties prior to manufacturing of the first cGMP batch.
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 the approved instructions for the manufacture of a lot of DRUG PRODUCT.
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 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.
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 prepared by BLP in accordance with CGMP requirements which now or hereafter govern the Processing of Drug Substance into Drug Product.
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.