Engineering Batch definition
Engineering Batch means any Batch Manufactured under the relevant Statement of Work that is intended to demonstrate the transfer of the Process to the Facility.
Engineering Batch means a Batch produced from an Engineering Run.
Engineering Batch means a Batch that is intended to demonstrate the transfer of the Manufacturing Process to the Facility. After Manufacture, Client shall have the right to make whatever further use of non-cGMP Engineering Batches as it shall determine, provided that Client pays for such Batches according to this MSA, such use is not for human use and does not violate any Applicable Laws. SBL makes no warranty that Engineering Batches will meet cGMP or the Specifications. If SBL determines that an Engineering Batch does meet cGMP and the Specifications, it will release such Engineering Batch as a cGMP Batch, and thereafter Client shall be entitled to use such Engineering Batch for human use.
Examples of Engineering Batch in a sentence
The Parties shall jointly define the objectives, success criteria, and reporting requirements for each Engineering Batch.
More Definitions of Engineering Batch
Engineering Batch means a Batch that is intended to demonstrate the transfer of the Process to the Facility.
Engineering Batch is defined in Section 9.3 (Engineering Batches).
Engineering Batch means: the Product obtained from one production run at scale under GMP conditions using the Draft Procedures and Draft GMP Specification and final process as agreed after the Process Development Phase, which Product will be tested to see if the Process Development Objectives can be met at large scale, which Product is not intended for use in Clinical Studies.
Engineering Batch means the first Batch at scale after the pilot Batch in which Lonza will use commercially reasonable efforts but does not warrant to meet cGMP;
Engineering Batch means a Batch of Product identified as an Engineering Batch on Schedule 7.
Engineering Batch means a test Batch manufactured in a CGMP-qualified manufacturing suite at the same scale and with a Manufacturing Process similar to the intended CGMP Manufacturing Process of an intended CGMP Batch, but not subject to CGMP and without any obligation to meet any Specifications.
Engineering Batch a Batch that is manufactured in a cGMP Facility at scale using the Process but which is not intended for human use and is identified as such in the applicable SoW;