Manufacturing SOPs definition
Examples of Manufacturing SOPs in a sentence
Arena shall ensure that all Finished Product supplied to Eisai hereunder by Arena shall be manufactured in accordance with the applicable Manufacturing SOPs, the Quality Agreement, GMP and all other Applicable Laws, and all other applicable requirements of Regulatory Authorities, (collectively, “Regulatory Standards”) and shall conform to the applicable warranty set forth in Section 6.13.
Novasep shall permit Celladon to inspect the Novasep Facility during normal business hours and review such documents as is reasonably necessary for the purpose of assessing Novasep’s compliance with the Manufacturing Process, the Manufacturing SOPs, cGMP, the Specifications, applicable requirements of Regulatory Authorities, and applicable manufacturing controls.
Any actual costs incurred by Novasep in making changes to the Manufacturing Process or the Manufacturing SOPs that are requested by Celladon shall be reimbursed by Celladon, in amounts to be agreed by the parties in writing prior to performing such changes.
Arena shall ensure that all Product supplied to Eisai or the applicable Designated Distributor hereunder by Arena shall be manufactured in accordance with the applicable Manufacturing SOPs, the applicable Quality Agreement, GMP and all other Applicable Laws, and all other applicable requirements of Regulatory Authorities, (collectively, “Regulatory Standards”) and shall conform to the applicable warranty set forth in Section 12.2.
Subject to Section 5.3, Arena shall label and package (in appropriate primary, secondary and tertiary packaging), including production of Package Inserts, Product to be supplied in accordance with such agreement of the Parties, the applicable Manufacturing SOPs, and Applicable Laws of each applicable country in the Territory, for delivery to Eisai or the Designated Distributor under this Agreement.
Without limiting the generality of the foregoing, upon Celladon’s written request, Novasep shall provide to Celladon all documents specified in the Quality Agreement, including, by way of example only, the complete Master Batch Records and specific Manufacturing SOPs and updates as defined in the Quality Agreement, copies of executed, completed Batch Records for each Batch, and all relevant documents relating to the Manufacturing Process or any Novasep Project IP used in manufacturing Product.
Any such technology transfer pursuant to this Section 8.4 shall include the Master Batch Records, Manufacturing SOPs, Quality Control Procedures, the design of the Modified Novasep Facility, and all necessary portions of the Novasep Project IP used by Novasep in the manufacture of Product.
Novasep shall label and package Product supplied hereunder in accordance with the applicable Manufacturing SOPs, the Quality Agreement, Celladon’s reasonable directions and Applicable Law regarding pharmaceutical products shipped in bulk.
No changes to Manufacturing Process, the Manufacturing SOPs, the Master Batch Records, material and in-process specifications and analytical procedures for raw materials, in-process testing or batch release testing shall be made except in accordance with the change control procedure set forth in the Quality Agreement.
Upon Equillium’s written request, Biocon shall provide to Equillium copies of the complete Master Batch Records and specific Manufacturing SOPs and updates as defined in the Quality Agreement, copies of the relevant documents identifying any Biocon technology used in the Manufacture of Clinical Material under the Manufacturing SOPs, and all CMC Data.