Released Executed Batch Record definition

Released Executed Batch Record means the completed batch record and associated deviation reports, investigation reports, and Certificates of Analysis created for each Batch of Product as specified in the Product Master Plan.
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Released Executed Batch Record means the completed Batch record and associated exception reports, and the QCMD created for each Batch of Supplied Product.
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Released Executed Batch Record means the completed batch record (in the form of the applicable Master Batch Record) and associated deviation reports, investigation reports, and Certificates of Analysis (provided in accordance with the Quality Agreement) created for each Batch of the Product and approved as released to RevitaLid under cGMPs by Nephron.
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Examples of Released 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 Released Executed Batch Record

Released Executed Batch Record means the completed batch record (in the form of the applicable Master Batch Record) and associated deviation reports, investigation reports, and Certificates of Analysis (provided in accordance with the Quality Agreement) created for each Batch and approved as released to CLIENT under cGMP by BAXTER's quality assurance department.
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Released Executed Batch Record means the completed batch record and associated deviation reports, investigation reports, and Certificates of Analysis created for each Batch of Client Product, in the form agreed upon by the parties, which shall be based on the standard form used by Althea.
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Released Executed Batch Record means the completed batch record (in the form of the applicable Master Batch Record) and associated deviation reports, investigation reports, and Certificates of Analysis (provided in accordance with the Quality Agreement) created for each Batch of Bulk Drug Substance and approved as released to HALOZYME under cGMP by AVID.
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Released Executed Batch Record means the completed batch record and associated documentation as described in the Quality Agreement.
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Released Executed Batch Record means the completed batch record and associated deviation reports, investigation reports and certificates of analysis created by LONZA for each Batch Manufactured hereunder, including written confirmation that such batch record has been reviewed and approved by LONZA's quality assurance unit.
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Released Executed Batch Record means the completed batch record and associated deviation reports, investigation reports and certificates of analysis created by *Indicates that material has been omitted and confidential treatment has been requested therefor. All such omitted material has been filed separately with the Commission pursuant to Rule 24b-2.
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Released Executed Batch Record means the completed batch record (in the form of the applicable Master Batch Record) and associated deviation reports, investigation reports, and Certificates of Analysis (provided in accordance with the Quality Agreement) created for each Batch and approved as released to CLIENT under cGMP by ▇▇▇▇▇▇'▇ quality assurance department. 1.33 "Rolling Forecast" shall be defined in Section 4.1 1.34 "Shipping Instructions" shall mean the shipping instructions for Product Produced under this Agreement set forth on [CONFIDENTIAL TREATMENT REQUESTED], as amended, supplemented or restated from time to time in accordance with Section 2.2.2. 1.35 "Stability/Validation Batches" shall mean (a) with respect to each Kit Component (other than the reaction vial specified in [CONFIDENTIAL TREATMENT REQUESTED] (as amended, supplemented or restated from time to time in accordance with Section 2.2.2)), the first [CONFIDENTIAL TREATMENT REQUESTED] cGMP batches thereof Produced under this Agreement, and (b) with respect to the reaction vial specified in [CONFIDENTIAL TREATMENT REQUESTED] (as amended, supplemented or restated from time to time in accordance with Section 2.2.2), the first cGMP batch thereof Produced under this Agreement. Article 2, PRODUCT MASTER PLAN 2.1
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