Quality Release definition

Quality Release means certification by Takeda’s quality control department that Drug Substance Manufactured by or on behalf of Takeda complies with the Quality Agreement and Takeda’s quality release specifications as confirmed by release testing.
View Source
Quality Release means certification by Takeda’s quality control department that Drug Substance or Drug Product Manufactured by or on behalf of Takeda complies with its quality release specifications as confirmed by release testing.
View Source
Quality Release means an improvement that is specific to a single or small number of issues or errors, may not have general availability, and may be released out-of-cycle from a fully QA-ed release that results in a version number change. A “Patch release” would be a type of Quality release.
View Source

Examples of Quality Release in a sentence

  • With each batch of Drug Substance delivered by Takeda pursuant to Section 8.1 hereof, Takeda shall provide all Batch Documentation for such batch, including a certificate of analysis, Quality Release and certificate of conformance, in accordance with the terms of the Quality Agreement.

  • Prior to delivery by Takeda pursuant to Section 8.1 hereof, Takeda shall undertake release testing to obtain a Quality Release for each batch of the Drug Substance that is Manufactured pursuant to a Purchase Order and in accordance with the terms of the Quality Agreement.

  • Prior to delivery by Takeda pursuant to Section 7.1, Takeda shall undertake release testing to obtain a Quality Release for each batch of the Drug Substance or Drug Product that is Manufactured pursuant to a Purchase Order accepted by Takeda.

  • With each Batch of Product(s) delivered by Supplier pursuant to Section 9.1, Supplier shall provide for each Batch all Batch Documentation, including a certificate of analysis, Quality Release and certificate of conformance, in each case in accordance with the terms of the Quality Agreement.

  • Prior to delivery by Supplier pursuant to Section 9.1, Supplier shall undertake release testing to obtain a Quality Release for each Batch of the Product(s) that is Manufactured pursuant to a Purchase Order and in accordance with the terms of the Quality Agreement.

  • Procedures for Quality Release and authorization to ship will be included in the Quality Agreement.

  • Manufacturer and Quality Release of Product [***] Contract Manufacture of Product [***] Quality Control Testing of Product [***] Stability Testing of Product [***] GDSVF&H\1564504.2 [***] CONFIDENTIAL PORTIONS OF THIS DOCUMENT REDACTED AND SEPARATELY FILED WITH THE COMMISSION.

  • Sandoz shall provide to RareGen notice of its achievement of the Quality Release Milestone together with the Certificates of Analysis with respect to the Quality Release Milestone Units (the delivery of which shall constitute sufficient evidence of Sandoz’s achievement of the Quality Release Milestone), and RareGen shall pay such amount within fifteen (15) days after receipt thereof.


More Definitions of Quality Release

Quality Release means certification by Supplier’s quality control department that each Product that is Manufactured by or on behalf of Supplier complies with the Quality Agreement and Supplier’s quality release specifications as confirmed by release testing.
View Source