Batch Disposition. Prior to the later of (i) thirty (30) days after Closing and (ii) ten (10) days following the date on which Aeglea or its applicable Affiliate receives analysis results and batch documentation reasonably necessary to affect the following batch release, Aeglea shall, or shall cause one or more of its Subsidiaries to, perform batch disposition and release of 2 mg vials of batch number B23020012 of the Inventory produced by Aeglea or one or more of its Subsidiaries to Immedica for secondary packaging.
Batch Disposition. 7.2.1 For each batch, C*P will provide the documentation required in Appendix III.
Batch Disposition. For each batch, Fresenius will provide release documentation as defined in Appendix 111 which complies with the provisions set forth herein. Fresenius will provide a standard Certificate of Analysis indicating the test results and specification of each test performed, as well as a signed Certificate of Compliance confirming that the PRODUCTS have been manufactured, tested and stored according to the requirements of the Master Production Record, and in conformance to the Production Standards. Fresenius will provide copies to TransMedics of the batch documentation (Manufacturing Work Order and Packaging Work Order) for the first three commercial lots and one per year thereafter.
Batch Disposition. 7.2.1 For each batch, C*P will provide the documentation required in Appendix III.
7.2.2 Certificate of Compliance/Analysis
7.2.2.1 C*P is responsible for ensuring and certifying that the PRODUCTS have been manufactured according to the specifications/procedures documented in the Master Production Records.
7.2.2.2 C*P Qualified Person/QA Representative will sign a Certificate of Compliance confirming that the PRODUCTS have been manufactured, packaged, tested and stored according to the requirements of the Master Production Record and the Drug Product Specification.
7.2.2.3 C*P will provide a Certificate of Analysis indicating the test result from each test performed.
Batch Disposition. 8.3.1 For each batch, PYRAMID will provide to XERIS the released Batch Record Package for review.
8.3.2 PYRAMID is responsible for ensuring the product has been produced according to the Product Specifications, procedures documented in the Batch Production Records, and this Quality Agreement. PYRAMID will provide to XERIS a Certificate of Compliance.
Batch Disposition. 7.2.1 For each batch, Xxxxxx will provide the documentation required in Appendix II.
Batch Disposition. 5.2.1 For each batch of API Avecia QA will provide to Stressgen QA copies of the release, executed batch record, Certificate of Analysis, Certificate of Conformance, any deviation/change control reports, and copies of supporting Analytical Raw Data.
5.2.2 Avecia QA is responsible for ensuring that the API has been manufactured according to the Specifications, Procedures and Master Batch Records and cGMP.
5.2.3 The release of the API for delivery to Stressgen is the responsibility of Avecia QA. [*] = CONFIDENTIAL TREATMENT REQUEST(ED).
5.2.4 It is the responsibility of Avecia QA Manager in conjunction with Stressgen QA to review and decide on the disposition of potentially Non Conforming Materials.
5.2.5 Avecia QA will carry out a Product Quality Review at the end of each campaign of manufacture and indicate the findings to Stressgen QA in a summary report.
Batch Disposition. 7.2.1. For each batch, BAXTER will provide the documentation required in Appendix II.
Batch Disposition. 5.2.1 For each batch of API, Avecia QA will provide to Nuvelo copies of the release, executed batch record, Certificate of Analysis, Certificate of Conformance, any deviation/change control reports. Nuvelo will review and approve, as appropriate, the batch record and then accordingly forward a signed-off copy of the API disposition form to Avecia as confirmation of Nuvelo’s acceptance of the batch.
5.2.2 Avecia QA is responsible for ensuring that the API has been manufactured according to the Specifications attached hereto as Appendix 6, Standard Operating Procedures, Master Batch Records and cGMP.
5.2.3 Reprocess/Rework: Avecia QA will not internally authorise any rework without written prior approval from Nuvelo. Reprocessing may be performed at Avecia with internal approval. The details of the reprocessing will be included in the batch record. Approval from Regulatory Affairs (RA), QA and PSM management will be required for any rework activities.
5.2.4 Nuvelo QA must respond within 2 business days to any Avecia QA issues reported during batch disposition.
5.2.5 The release of the API ready for shipping is the responsibility of Avecia QA.
5.2.6 Avecia QA will be responsible for ensuring that appropriate Batch Records are copied and dispatched to Nuvelo QA within 10 business days after final disposition. 5.2.7 Responsibilities for shipment of the API are detailed in Appendix 5.
Batch Disposition
