Manufacturing Records means all documents relating to the Manufacture of a Batch, including manufacturing instructions, deviations, test results, out of specification results, investigations, bills of materials and certificates of analysis.
Manufacturing Records means manufacturing, facility/systems and environmental monitoring and cleaning, packaging and quality control and quality assurance records generated by Medeva in the course of the Manufacture, including, without limitation, the Manufacturing Instructions, production, packaging, quality control, and quality assurance records.
Manufacturing Records means, for a shipment of Product, the Batch records, certificate of analysis, certificate of conformity, BSE/TSE certificate and any other documents Specified in Appendix D of the Quality Agreement;
Examples of Manufacturing Records in a sentence
At any time during and after the Term, and from time to time, promptly upon its request, RELYPSA shall be entitled to review and receive copies of Manufacturing Records.
Vendor shall make Manufacturing Records available for inspection, audit and copying by Keryx and its representatives and agents, including Keryx’s auditors, at no cost to Keryx, upon reasonable request during normal business hours.
The Fiskeneasset anorthosite is associated with ultramafics, chromitites, gabbros and leucogabbros and presents chemical consanguinity with the adjacent amphibolites.
In consideration of the amounts paid hereunder, PATHEON shall deliver to RELYPSA in accordance with the terms hereof all relevant information including Manufacturing Records that is obtained by PATHEON in the course of performing the Services and supplying the Bulk and Finished Product, and that is reasonably requested by RELYPSA.
HD shall maintain true and complete books and records (including, without limitation, all Manufacturing Records) of all data relating to the manufacture, supply and sale of Products.
More Definitions of Manufacturing Records
Manufacturing Records means manufacturing, facility/systems and environmental monitoring and cleaning, packaging and quality control and quality assurance records generated by Oravax in the course of the Manufacture of the Products;
Manufacturing Records means all Specifications, formulations, processes and controls, including all supporting and historical data, product samples, technology transfer, laboratory data, development documentation equipment and other historical validation data and all related regulatory and compliance documents and information and such further information and documentation as HD shall reasonably request to enable it to manufacture and supply Products in accordance with the terms and conditions set forth herein.
Manufacturing Records means all documents created by LANXESS, any LANXESS Affiliate, or subcontractor of LANXESS or an Affiliate, relating to the production of MFA or the Manufacture of Bulk Intermediate or Bulk Drug, including the Master Batch Record, Batch records, deviation reports, test results, non-conformance reports, Raw Materials documentation and Certificates of Analysis and/or Compliance.
Manufacturing Records means all filings, records, and other documents (whether in hardcopy or electronic form) Controlled by ALZA (directly or through its Affiliates) pertaining to the manufacture of Dapoxetine or any Agreement Product, including the portions of any such documents bearing Know-How relating to the manufacture of Dapoxetine or any Agreement Product, the CMC portion of all ALZA Regulatory Submissions and ALZA Marketing Authorizations for Dapoxetine or any Agreement Product, all DMFs for Dapoxetine or any Agreement Product, together with all amendments and supplements, in support thereof, records used to obtain and maintain ALZA Marketing Authorizations or ALZA Regulatory Submissions, and records needed to support clinical development of Dapoxetine or any Agreement Product.
Manufacturing Records means the detailed written instructions describing the manufacturing of the Finished Product, including the records setting out the compounding (weighing-compounding instructions), processing (manufacturing instructions), secondary packaging (packaging instructions), quality control testing (quality control instructions), storage (part of the manufacturing instructions) and shipping (if applicable) (part of the manufacturing instructions) of the Finished Product, which are created by Supplier through implementation of the Specifications or any other instructions given by the Purchaser, and have been approved and countersigned by Purchaser;
Manufacturing Records has the meaning set forth in Section 6.12.
Manufacturing Records means all filings, records, and other documents (whether in hardcopy or electronic form) Controlled by ALZA (directly or through its Affiliates) pertaining to the manufacture of Dapoxetine or any Existing Product, including the portions of any such documents bearing Know-How relating to the manufacture of Dapoxetine or any Existing Product, the chemistry, manufacturing and controls portion of all Regulatory Submissions and Existing Product Registrations for Dapoxetine or any Existing Product, all drug master files for Dapoxetine or any Existing Product, together with all amendments and supplements, in support thereof, records used to obtain and maintain Existing Product Registrations or Regulatory Submissions, and records needed to support clinical development of Dapoxetine or any Existing Product.