Batch Release definition

Batch Release means the final sign-off by a party's quality department marking the culmination of the quality process through which a batch of Product is shown to conform to all aspects of the Manufacturing Standards.

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Batch Release means a release of any Batch by a Qualified Person for distribution or further processing confirming that the Batch is in accordance with the relevant requirements for human use (as defined in Directive 2001/83/EC for medicinal products for human use);

Batch Release means the final sign-off by Gensia Sicor's Quality Department marking the culmination of the quality process by which a batch of Product is shown to conform to all aspects of the Manufacturing Standards.

Examples of Batch Release in a sentence

• For the European Community, the official batch release procedure for medicinal products for human use is specified, in document "Administrative EC Batch Release Procedure III/3859/92" and different specific batch release procedures.

• The CTSU must also provide the CSC or designee with Certificate of Analysis (CofA) and the Pack Batch Release Certificate for each batch of an IMP supplied which is considered the technical green light.

• The CTSU’s issue of the Certificate of Analysis (CofA) for the Bulk Formulated Product and the Pack Batch Release Certificate of the finished drug product, is considered the “Technical Green Light” for the IMP to be released.

• For the sake of clarity only, and consistent with the terms of delivery established in Section 12.1 of the Agreement, any risk of loss and other damage to any Metreleptin Batches shipped prior to Batch Release will pass to Aegerion once Sandoz has loaded said Batches onto Aegerion’s designated carrier.

• Each shipment of Product shall be accompanied by a Certificate of Analysis describing all current requirements of the Specifications, results of test performed, as well as a Batch Release Sheet certifying that the batch of Product supplied has been manufactured, controlled and released according to the Specifications, current DMFs and all relevant and current GMP requirements at the Facility stipulated under Section 3.1 above.

• Sandoz shall immediately notify Amylin of any Product being ready for dispatch, which shall be shipped as soon as possible upon Amylin’s demand for delivery and in no event later than [***] after Batch Release by Sandoz.

• SUPPLIER shall be responsible for securing batch release relating to Product with a European Official Medicinal Control Laboratory and National Batch Release and shall provide DISTRIBUTOR with such relevant release documentation, information forms and certificates as specified in ANNEX E.

• By way of example, if a Batch Release Date is May 15, the first calendar month anniversary would be June 15.

• For the European Union, the official batch release procedure is specified in document ‘Control Authority Batch Release of Vaccination and Blood Products, 2001’ or subsequent versions and in different specific batch release procedures.

• The payment for each of the Metreleptin Batches delivered prior to Batch Release is due in accordance with the current payment terms of [***] after the relevant Sandoz Release has occurred.

More Definitions of Batch Release

Batch Release means the final written approval, signed by NOF’s (or its subcontractor’s or CMO’s, as applicable) relevant quality assurance (“QA”)/quality control (“QC”) officer, marking the culmination of the quality process through which a Batch is shown to conform to cGMPs, the applicable Specifications, and all applicable Laws.

Batch Release means the Qualified Person (“QP”) signature on the Certificate of Analysis in Germany;

Batch Release means the release of gaseous or liquid effluent of a discrete volume.