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 a Batch that is intended to demonstrate the transfer of the Manufacturing Process to the Facility, as described in Clause 2.2.
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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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Examples of Engineering Batches in a sentence

  • Following completion of Engineering Batches, before proceeding to Process Validation Batches, the Parties shall agree, in writing, that the Process is validation ready.

  • In accordance with the Process Engineering Protocols, BioVectra will supply Keryx with (i) Batch Documentation from the Engineering Batches, and (ii) Product from the Engineering Batches for evaluations, including but not limited to [**] In the event that Process Engineering does not adhere to the Process Engineering Protocols at any point during Process Engineering, the Parties will work [**] to resolve any issues that prevent such adherence, which may include [**].

  • For Engineering Batches, Lonza shall, at its own expense, reprocess any Engineering Batch or, if reprocessing is not possible, replace any Engineering Batch that failed to conform with the Specifications (a “Failed Engineering Batch”).

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

  • Unless otherwise agreed to by the Parties in writing, the costs associated with such testing and review shall be borne by the Party against whom the independent laboratory rules.7.3.3 For Engineering Batches, Lonza shall, at its own expense, reprocess any Engineering Batch or, if reprocessing is not possible, replace any Engineering Batch that failed to conform with the Specifications (a “Failed Engineering Batch”).

  • A total of 8 teams participated, one from each class of the Chemical and Materials Engineering Batches.

  • SYNCO agrees to perform the number of Engineering Batches indicated in the applicable Service Specific Addendum, which Engineering Batches shall result in Product manufactured under GMP which is for confirmation purposes only, but not for Clinical Studies and/or commercial use.


More Definitions of Engineering Batches

Engineering Batches means a Batch that is intended to demonstrate the functionality of the Manufacturing
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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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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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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.

  • Engineering means the application of scientific knowledge for the design, control, or use of building structures, equipment, or apparatus.

  • cGMP means current Good Manufacturing Practice as set forth in the United States Federal Food, Drug, and Cosmetic Act, as amended, and includes all rules and regulations promulgated by the FDA thereunder.

  • engineering services means infrastructure for –

  • 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.

  • Drug Substance means an active ingredient that is intended to furnish pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure or any function of the human body, but does not include intermediates used in the synthesis of such ingredient.

  • Recalibration means the adjustment of all DRG weights to reflect changes in relative resource consumption.

  • Manufacturing means all activities related to the manufacture of a Compound, including planning, purchasing, manufacture, processing, compounding, storage, filling, packaging, waste disposal, labeling, leafleting, testing, quality assurance, sample retention, stability testing, release, dispatch and supply, as applicable.

  • Manufacturing Site means a location where a manufacturing

  • 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.

  • Engineering control means the use of substitution, isolation, ventilation, and equipment modification to reduce exposure to SARS-CoV-2 virus and COVID-19 disease related workplace hazards and job tasks.

  • Manufacturing Process means any process for—

  • Product Specifications means the specifications, features and/or terms of any "Contract" (as defined in the LME Rules) listed for trading on the LME, as described in the LME Rules;

  • Testing means that element of inspection that determines the properties or elements, including functional operation of materials, equipment, or their components, by the application of established scientific principles and procedures.

  • Calibration means the determination of (1) the response or reading of an instrument relative to a series of known radiation values over the range of the instrument, or (2) the strength of a source of radiation relative to a standard.

  • Fluoroscopic imaging assembly means a subsystem in which X-ray photons produce a visual image. It includes the image receptor(s) such as the image intensifier and spot-film device, electrical interlocks, if any, and structural material providing linkage between the image receptor and diagnostic source assembly.

  • Product Specification means a product specification for a Medical Device set out in Schedule 2;

  • Feedstock means a solid waste that will readily decompose during the composting process including but not limited to yard waste, agricultural waste, animal waste, food scraps, animal carcasses, raw rendering material, and mixed solid waste.

  • external engineering service means an engineering service situated outside the boundaries of a land area and that is necessary to serve the use and development of the land area;

  • Bulk drug substance means any substance that is represented for use, and that, when used in the

  • technical specification means, with respect to any Software, the document setting forth the technical specifications for such Software and included in the Statement of Work.

  • Laboratory or “LANL” means the geographical location of Los Alamos National Laboratory, a federally funded research and development center owned by the DOE / NNSA.

  • API means American Petroleum Institute.

  • Technical Specifications means the detailed requirements for the Work furnished by the Architect and set forth in Book 3 of the Contract Documents.

  • Assay means a laboratory analysis of Crude Petroleum to include the following: A.P.I. Gravity, Reid vapor pressure, composition, pour point, water and sediment content, sulfur content, viscosity, distillation, hydrogen sulfide, flash/boiling point and other characteristics as may be required by Carrier.

  • Remanufacturing means the activity of overhauling, retrofitting, fabricating, or repairing a product or its component parts for ultimate sale at retail.