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

Deviation(s) from the Master Batch Record must be documented as required by cGMP in the Released Executed Batch Record for that Batch.
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.
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.
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.
Any such Client Product rejected hereunder, shall be referred to as “Rejected Product.” The parties may mutually agree in writing to multiple release cycles requiring more than one Released Executed Batch Record with respect to certain Purchase Orders issued under this Agreement, and the procedures contemplated hereunder will apply to each such Released Executed Batch Record.

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

Executed Batch Record has the meaning set forth in the Quality Agreement.

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

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