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.

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 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

Examples of Executed Batch Record in a sentence

• Xxxxxx shall also indicate on the final page of the Released Executed Batch Record that all batch Production and control records have been reviewed and approved by the appropriate quality control unit.

• 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.

• Xxxxxx shall provide Client with the Released Executed Batch Record in a form reasonably suitable for Client’s submission to the FDA.

• Deviation(s) from the Master Batch Record must be documented as required by cGMP in the Released Executed Batch Record for that Batch.

• Any deviation from the manufacturing process specified in the Master Batch Record must be documented in the copy of the Executed Batch Record for that Batch.

More Definitions of Executed Batch Record

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

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 has the meaning set forth in the Quality Agreement.

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

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.