Manufacturing Records definition

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. 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 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.

Examples of Manufacturing Records in a sentence

• Batch Manufacturing Records should be prepared for each batch of product.

• Note : The Tender Inviting Authority, or his authorized representative(s) has the right to ask/inspect Batch Manufacturing Records after the batches are offered for inspection and sampling or after delivery of the product(s).

• Batch Manufacturing Records in Navinta's ANDA describe the complete procedures for manufacturing the accused ANDA Products.

• Regulations Regarding Property Used for Methamphetamine Manufacturing Records Required to be Filed and KeptPolice officers who make arrests at “clandestine lab sites” must notify the local health department, the duty officer, and child protection of the arrest and the location of the site.

• Indeed, at the time Defendants made these statements, management had been aware since May 2016 of more than 1,200 errors in its Batch Manufacturing Records, as noted in the FDA’s Unit VII EIR, yet Defendants allowed these errors to repeat month after month without ever identifying root causes for these errors or addressing any additional corrective actions.

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 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.

Manufacturing Records means, for a shipment of Product, the following documents: the batch records, certificate of analysis, certificate of conformity, and the BSE/TSE certificate; "Manufacturing Scale Up" means the purchase, installation and validation of equipment and the undertaking of such other capital improvements required to enable Patheon to manufacture Product in batches greater than [***];

Manufacturing Records has the meaning ascribed thereto in Section 6.6 of this Agreement.

Manufacturing Records. (manufacturing build records, device master records in the form and version as of the Effective Date, device history records and lot history records), and (ii) “Development Records” (design history files) of the Acquired Technology.

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 has the meaning set forth in Section 6.3 (Manufacturing Records). [****] = [CONFIDENTIAL PORTION HAS BEEN OMITTED BECAUSE IT (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED