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.
Released Executed Batch Record means the completed Batch record and associated exception reports, and the QCMD created for each Batch of Supplied Product.
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.
Examples of Released 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.
Within [***] from the date of completion of testing and Althea’s release of Batch of Client Product, Xxxxxx shall promptly forward to Client, or Client’s designee, copies of the Released Executed Batch Record and samples of such Batch.
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.
Released Executed Batch Record means the completed batch record executed by Xxxxxx and associated deviation reports, investigation reports, and Certificates of Analysis created for each Batch of Client Product 133 “Services” means the services performed or to be performed by Xxxxxx under this Agreement, including Production.
Released Executed Batch Record means the completed Batch record and associated deviation reports, investigation reports and certificates of analysis created by XXXXX for each Batch Manufactured hereunder, including written confirmation that such Batch record has been reviewed and approved by DIXIE's quality assurance unit.
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.
Released Executed Batch Record means the completed batch record and associated documentation as described in the Quality Agreement.
Released Executed Batch Record means the completed batch record and associated deviation reports, investigation reports and certificates of analysis created by BAXTER for each Batch released by BAXTER. The Released Executed Batch Record shall be sent to PRAECIS in accordance with Section 9.3. The Released Executed Batch Record shall be in a format as agreed between the parties and shall contain at a minimum the information set forth in Exhibit 2 to this Agreement.
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 XXXXXX'x 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