Engineering Batches definition

Engineering Batches means a Batch that is intended to demonstrate the transfer of the Manufacturing Process to the Facility.
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Engineering Batches means batches (complete and/or incomplete) undertaken during the Process Implementation Phase at commercial scale in the Suite to determine whether newly installed or modified equipment operates as intended under process conditions.
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Engineering Batches means batches of Product manufactured immediately in advance of cGMP Manufacture for the purposes of testing the Process at full scale operation, such batches to be manufactured under conditions that will permit designation of the batch as a cGMP Batch in the event that all cGMP requirements are met and the Process and Specification for Product are according to the cGMP Batch Records;
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Examples of Engineering Batches in a sentence

  • Lonza makes no warranty that Engineering Batches will meet cGMP or the Specifications.

  • In the event that there is a material difference in the process assumptions as compared with the process results demonstrated during the manufacture of Engineering Batches, the Parties shall meet to discuss in good faith a revision to the Batch Price to reflect such difference.

  • Lonza shall manufacture Engineering Batches in accordance with the Project Plan.

  • Customer shall have the- right to make whatever further use of the non-cGMP Engineering Batches as it shall determine, provided that Customer pays for such Batches, such use is not for human use and does not violate any Applicable Laws.

  • Regardless of whether any Engineering Batch meets cGMP or the Specifications, Customer shall pay to Lonza the Price for such Engineering Batch that were executed in accordance with mutually agreed plans and meet a mutually agreed specification for bioburden, plus the Raw Materials Fee associated with such Engineering Batches.

  • Customer shall have the right to make whatever further use of the non-cGMP Engineering Batches as it shall determine, provided that Customer pays for such Batches, such use is not for human use and does not violate any Applicable Laws.

  • LONZA makes no warranty that Engineering Batches will meet cGMP or the Specifications.

  • In the event that there is a material difference in the process assumptions as compared with the process results demonstrated during the manufacture of Engineering Batches, the Parties shall meet to discuss in good faith a revision to the Batch price to reflect such difference.

  • If called for in the Project Plan, LONZA shall perform manufacture Transfer Batches and/or Engineering Batches in accordance with the Project Plan.

  • Senti will have the right to make whatever further use of such Engineering Batches as it will determine; provided that such use does not violate any Laws.


More Definitions of Engineering Batches

Engineering Batches means a Batch that is intended to demonstrate the transfer of the Manufacturing Process to the Facility. “External Laboratories” means any Third Party instructed by Lonza, with Customer’s prior consent, which is to conduct activities
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Engineering Batches means a Batch that is intended to demonstrate the functionality of the Manufacturing
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Related to Engineering Batches

  • 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.

  • cGMP means current Good Manufacturing Practices as specified in the United States Code of Federal Regulations, ICH Guideline Q7A, or equivalent laws, rules, or regulations of an applicable Regulatory Authority at the time of manufacture.

  • GMP means the amount proposed by Contractor and accepted by Owner as the maximum cost to Owner for construction of the Project in accordance with this Agreement. The GMP includes Contractor’s Construction Phase Fee, the General Conditions Cost, the Cost of the Work, and Contractor’s Contingency amount.