Executed Batch Record definition

Executed Batch Record means an executed batch record for a batch of Product, including a certificate of analysis and any associated deviations or investigation reports.

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Executed Batch Record means the executed and completed Master Batch Record for each batch of Drug Product manufactured pursuant to the terms of this Agreement.

Executed Batch Record means the completed batch record (dispositioned by Baxter as released, rejected or aborted) and associated deviation reports, and if applicable, a Lot QC Data Packet for each Batch of Product.

Examples of Executed Batch Record in a sentence

The Certificate of Analysis for each Batch delivered shall be included with the Released Executed Batch Record and shall set forth the items tested, Specifications, and test results.
Deviation(s) from the Master Batch Record must be documented as required by cGMP in the Released Executed Batch Record for that Batch.
Client Product: Within [***] from the date of completion of Althea’s testing and release of each Batch of Client Product, ▇▇▇▇▇▇ shall promptly forward to Client, or Client’s designee, copies of the Released Executed Batch Record any other release documents associated with the manufacture of such Batch as set forth in the SOW or Quality Agreement.
A▇▇▇▇▇ shall also indicate on the final page of the Executed Batch Record that all batch Production and control records have been reviewed and approved by the appropriate quality control unit.
Within [***] from the date of completion of testing and Althea’s release of Batch of Client Product, ▇▇▇▇▇▇ shall promptly forward to Client, or Client’s designee, copies of the Released Executed Batch Record and samples of such Batch.

More Definitions of Executed Batch Record

Executed Batch Record means the batch record generated by Tekmira in its Manufacture of a specific GMP Batch, which GMP Batch record shall contain the information set forth in the MBR for such Product at such scale and such quality of manufacture

Executed Batch Record means production and control records prepared for each batch of Finished Product produced and shall include complete information relating to the production and control of each batch.

Executed Batch Record means the record prepared from the approved Master Batch Record, containing complete information relating to the production and control of a Lot.

Executed Batch Record means a compilation of records containing the Manufacturing history and control of a specific Batch. These records are generated by the Manufacturing and Quality Control personnel and reviewed and approved by the Quality Assurance personnel of the Manufacturing Party or its Affiliate, Sublicensee, Designated CMO or Secondary CMO, as applicable.

Executed Batch Record means the executed manufacturing instructions containing the complete documentation of all activities and measurements associated with production of a Lot of Bulk Product.

Executed Batch Record. (EBR) means the complete production record documenting the Manufacture of one Batch, in accordance with the Master Batch Record and contains a compilation of records containing the Manufacturing history and control of a Product, including the Certificate of Analysis. These records are generated by Corden’s Quality Control and reviewed and approved by Quality Assurance and are described more fully in the Quality Agreement. 1.9 “Binding Forecast” has the meaning set forth in Section 3.1(b). 1.10 “Business Day” means any day other than a Saturday or Sunday or a day that is a statutory holiday in Germany or the United States of America. 1.11 “Calendar Quarter” means the respective periods of three (3) consecutive calendar months ending on March 31, June 30, September 30 and December 31; provided, however, that (a) the first Calendar Quarter of the Term shall extend from the Effective Date to the end of the first complete Calendar Quarter thereafter; and (b) the last Calendar Quarter of the Term shall end upon the expiration or termination of this Agreement. 1.12 “Calendar Year” means the twelve-month period ending on December 31; provided, however, that (a) the first Calendar Year of the Term shall begin on the Effective Date and end on December 31, 20244; and (b) the last Calendar Year of the Term shall end on the effective date of expiration or termination of this Agreement. 1.13 “Certificate of Analysis” means a document signed by an authorized representative of Corden for each Batch of Product that provides full analytical results of the Batch, including the testing

Executed Batch Record shall have the same meaning as set forth in the Quality Agreement.