GMP Batch definition

GMP Batch means a Batch that is intended to meet GMP requirements.
GMP Batch means a Batch of Biologic supplied, or to be supplied, to Client hereunder that is manufactured in accordance with GMPs that meets the Specifications in the applicable SOW or Quality Agreement.
GMP Batch means a Batch that is intended to meet cGMP requirements.

Examples of GMP Batch in a sentence

Specifications and other criteria which have been mutually agreed by both parties to which cGMP Product must conform, including the test methods to be used in determining whether Product conforms thereto: at least two (2) weeks before the scheduled commencement of manufacture of the 1st GMP Batch.

DPT agrees that each GMP Batch produced hereunder shall be manufactured at the Facility, in accordance with cGMPs, at the time of delivery to Company, provided that the API intended for use in the GMP Batches conforms, at the time of delivery to DPT, to the specifications therefor.

If Alnylam accepts the terms of such GMP Batch Change Order in writing, then the relevant GMP Batch Work Order will be deemed amended to reflect those changes set forth in such Change Order.

Provider shall reduce the payment due under this Section 9.5 by a sum equal to the fee received by the third party customer (after accounting for out-of-pocket costs incurred by Provider to accomplish such mitigation) for the costs of Provider’s labor and equipment that Provider would have expended on manufacturing Synthorx’s non-cGMP or GMP Batch, as the case may be.

Tekmira shall be reasonable and use good faith in its considerations of draft GMP Batch Work Orders from Alnylam.


More Definitions of GMP Batch

GMP Batch means a Batch which is identified in a Statement of Work as a GMP Batch and which is or is intended to be manufactured during a GMP Stage and subject to Disposition, all in accordance with cGMP, and “GMP Product” shall mean the Product from or in the GMP Batch.
GMP Batch means a Batch manufactured according to GMP. [***] = CERTAIN CONFIDENTIAL INFORMATION CONTAINED IN THIS DOCUMENT, MARKED BY BRACKETS, HAS BEEN OMITTED BECAUSE THE INFORMATION (I) IS NOT MATERIAL AND (II) WOULD BE COMPETITIVELY HARMFUL IF PUBLICLY DISCLOSED.
GMP Batch means a Batch that is intended to meet cGMP requirements. *Confidential Treatment Requested.
GMP Batch means: a Batch manufactured after the Engineering Batch and after the GMP Specifications and the GMP Procedures have been agreed, that is required to be manufactured according to the GMP Procedures in all material respects, to comply with GMP Specifications and to be manufactured in accordance with GMP in all material respects.