non-GMP Batch definition

non-GMP Batch means any Batch intended for non-clinical use, including those intended to meet the requirement for pre-clinical use pursuant to cGLP requirements, such as, for example, a batch intended for use in GLP toxicology studies.
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non-GMP Batch means any Batch intended for non-clinical use, including those intended to meet the requirement for pre-clinical use pursuant to GLP requirements, such as, for example, a batch intended for use in GLP toxicology studies.
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Examples of non-GMP Batch in a sentence

  • In addition, to the extent reasonably requested by Alnylam, Tekmira will also supply Alnylam with samples of the applicable non-GMP Batch in an amount sufficient for Alnylam to conduct necessary testing of such non-GMP Batch.

  • Alnylam will provide Tekmira draft non-GMP Batch Work Orders and Other Supply Services Work Orders allowing for reasonable lead times deemed to be sufficient by action of the Joint Development and Manufacturing Committee.

  • In the event the Parties cannot agree upon the content of any non-GMP Batch Work Order or cannot agree upon a Change Order related to any non-GMP Batch Work Order, then the Joint Development and Manufacturing Committee shall be authorized to attempt to resolve such disagreement.

  • Each Party’s representatives on the Joint Development and Manufacturing Committee shall have the authority to sign, on behalf of their respective Parties, a non-GMP Batch Work Order, subject to any financial limits to the signing authority of the members of the Joint Development and Manufacturing Committee based on such Party’s internal controls.

  • Fujifilm warrants (as of the time of delivery) and covenants, as applicable, that, with respect to each non-GMP Batch that is a development batch, Fujifilm has [***] to ensure that the [***] (including [***]) set forth in the applicable documents.

  • Fujifilm warrants (as of the time of delivery) and covenants, as applicable, that, with respect to each non-GMP Batch that is a development batch, Fujifilm has used and will use commercially reasonable efforts to ensure that the Product meets the agreed specifications or targets (including [***]) set forth in the applicable documents).

Related to non-GMP Batch

  • Harvest batch means a specifically identified quantity of dried flower or trim, leaves, and other cannabis plant matter that is uniform in strain, harvested at the same time, and, if applicable, cultivated using the same pesticides and other agricultural chemicals, and harvested at the same time.

  • Batch means a specific quantity of Product that is intended to have uniform character and quality, within specified limits, and is produced according to a single manufacturing order during the same cycle of manufacture.

  • Master Batch Record means the document, proposed by Lonza and approved by Customer, which defines the manufacturing methods, test methods and other procedures, directions and controls associated with the manufacture and testing of Product.

  • MSAA Indicator Technical Specifications document means, as the context requires, either or both of the document entitled “Multi-Sector Service Accountability Agreement (MSAA) 2019-20 Indicator Technical Specifications November 5, 2018 Version 1.3” and the document entitled “Multi-Sector Service Accountability Agreement (MSAA) 2019-20 Target and Corridor-Setting Guidelines” as they may be amended or replaced from time to time;

  • Non-Conforming Product means a Product that does not conform to the Supplier’s Warranties.