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.
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
If Spectrum establishes that any shipment of a Product does not conform to the Product Requirements (“Nonconforming Product”), then Spectrum will give Hanmi written notice thereof as soon as practicable but in no event later than [***] from the date of delivery of both the Product and the Released Executed Batch Record and will, unless otherwise directed by ▇▇▇▇▇, return only the Nonconforming Product for further testing by ▇▇▇▇▇.
Within [***] from the date of delivery of both the Product and the Released Executed Batch Record to Spectrum, Spectrum will determine, based on agreed release testing procedures, whether such Product conforms to Product Specifications and the Master Batch Record (collectively the “Product Requirements”).
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 and associated deviation reports, investigation reports and certificates of analysis created by DOTTIKON for each Batch Manufactured hereunder, including written confirmation that such Batch record has been reviewed and approved by DOTTIKON'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 (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.
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
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