Master Batch Record. (MBR) shall mean the formal set of instructions for Production of Drug Product. The MBR shall be developed and maintained in ALTHEA’s standard format by XXXXXX, using CLIENT’s master formula and technical support.
Master Batch Record. The Client will provide the Specifications to Patheon and Patheon will manufacture Product in accordance with the Specifications. Patheon is responsible for preparing the master batch records for the Product, however, the Client is responsible to review and approve the master batch records prior to the manufacture of the Product unless otherwise agreed to in writing. Patheon will not make changes to master batch records except through the established Patheon change control system, and all master document revisions will be approved by the Client’s quality unit unless otherwise agreed to in writing. Any changes made to issued batch records (prior to master revisions) must be reviewed and approved by the Client’s quality unit prior to implementation unless otherwise agreed to in writing. Patheon will maintain a batch numbering system designed to assure traceability of the product and associated documentation.
Master Batch Record. (MBR) shall mean the formal set of instructions setting forth the procedure to be followed for the Production of Drug Product, including but not limited to the history of a Batch from the raw material stage up through and until completion of the Batch, a complete list of all active and inactive ingredients, components, weights and measures, descriptions of Drug Product containers, closures, packaging materials, and labeling and complete specifications for each.
Master Batch Record. The Client will provide the early development reports and CTM Specifications to Patheon and Patheon will manufacture the CTM in accordance with the Specifications. Patheon is responsible for preparing the master batch records for the CTM, however, the Client is responsible to review and approve such master batch records prior to the manufacture of the CTM. Patheon will not make changes to master batch records except through the established Patheon change control system, and all master document revisions will be approved by the Client’s quality unit. Any changes made to issued batch records (prior to master revisions) must be reviewed and approved by the Client’s quality unit prior to implementation unless otherwise agreed to in writing.
Master Batch Record. (MBR) shall mean the formal set of instructions for Production of Company Plasmid DNA. The MBR shall be developed and maintained in ALTHEA’s standard format by AXXXXX, using CLIENT’s master formula and technical support.
Master Batch Record. The original, approved template used for the execution of each Manufacturing Batch Record.
Master Batch Record. The Master Batch Record shall be reviewed and approved in writing by Patheon and by Client prior to commencement of Manufacturing Services. Any material change to an approved Master Batch Record shall be reviewed and approved in writing by Patheon and by Client prior to said change being implemented. Each batch of Product shall be manufactured by using a copy of the Master Batch Record. Each copy of the Master Batch Record for such batch of Product shall be assigned a unique batch number. Any deviation from the manufacturing process specified in the Master Batch Record must be documented in the batch record for that batch.
Master Batch Record. Prior to DMF Approval, CPI will manufacture and bulk package the Drug Resin Complex in accordance with the ANDA and applicable Laws. Following DMF Approval, CPI will manufacture and bulk package the Drug Resin Complex in accordance with the DMF and applicable Laws. CPI is responsible for preparing the master batch records for manufacture and bulk packaging of the Drug Resin Complex. Prior to DMF Approval, the Regulatory Consultant, is responsible to review and approve the master batch records for the manufacture and bulk packaging of Drug Resin Complex. Following DMF Approval, CPI will follow their approved SOP’s to fully investigate any “for cause” circumstances and provide Neos a written summary of those findings CPI will not make changes to master batch records except through an established change control system. CPI shall provide Neos with written notification of significant changes made to the Drug Resin Complex batch records that may directly impact Neos’s manufacture of Generic Tussionex.
Master Batch Record. Cangene will provide the Specifications to Patheon and Patheon will manufacture Product in accordance with the Specifications. Patheon is responsible for preparing the master batch records for the Product, however, Cangene is responsible to review and approve such master batch records prior to the manufacture of the Product. Patheon will not make changes to master batch records except through the established Patheon change control system, and all master document revisions will be approved by Cangene’s quality unit. Any changes made to issued batch records (prior to master revisions) must be reviewed and approved by Cangene’s quality unit prior to implementation unless otherwise agreed to in writing. Quality QG01-05-T001-01 Agreement
Master Batch Record. 4.2.1 Company will prepare Master Batch Records as required to execute the Process in accordance with the Process Specifications, this Agreement, any applicable Statement of Work, all Laws, and the Quality Agreement. Iovance will inform Company of any specific requirements Iovance may have relating to the Master Batch Records, including any information or procedures, including testing procedures, Iovance wishes to have incorporated therein and Company will reflect any such instructions provided by Iovance in the Master Batch Record. If Company intends to include in the Master Batch Record the use of any assay, medium, or other technology that either is not commercially available or is subject to a separate licensing or royalty payment, Company will inform Iovance of such intention in advance and the Parties will meet to discuss and attempt to agree in good faith on the terms of use of such non-commercially available materials or technology in the Process. Company will not incorporate any of Company’s Background Intellectual Property, or that of any Affiliate or Third Party, into the Process or the Master Batch Records without the prior written consent of Iovance.
4.2.2 Company will deliver iterative versions of the Master Batch Record to Iovance on timing set forth in each Statement of Work that calls for the preparation of a new Master Batch Record. Iovance will notify Company in writing of any objections or comments it has to the draft Master Batch Record, and upon such notification, representatives of Company and Iovance will meet promptly to resolve such objections. The Master Batch Record will be final when approved by Iovance and shall be deemed Iovance Confidential Information.
