Demonstration Batch definition

Demonstration Batch means a Batch used for process demonstration and engineering of some or all of the Process Services and/or demonstration and engineering of Production in Xxxxxx’x cGMP facility.
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Demonstration Batch a Batch which is manufactured in a non cGMP R&D facility for demonstration purposes and which is not intended for human use and is identified as such in the applicable SoW;
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Demonstration Batch means a Batch designated by Sponsor to demonstrate scalability of the process in the Fujifilm non-cGMP process development laboratory.
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Examples of Demonstration Batch in a sentence

  • Customer expressly agrees that Product produced pursuant to a Demonstration Batch or an Engineering Batch is not suitable, and will not be used, for human consumption or use or in clinic trials.

  • With respect to a Demonstration Batch or Engineering Batch, the Product Specifications for safety with regards to bioburden and endotoxin and identity of the Product as mutually agreed by the parties and set forth in the batch records.


More Definitions of Demonstration Batch

Demonstration Batch means one (1) successful commercial-scale production batch of Product manufactured from the Suite in accordance with in-process criteria. A successful Demonstration Batch is defined as a batch of the Product, meeting the criteria set forth in Schedule 5.1A.
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Demonstration Batch has the meaning provided in Section 3.4 of this Agreement.
Sample 1

Related to Demonstration Batch

  • Demonstration means a show, seminar, or contest in which barber services are rendered for the purpose of educating barbers.

  • Batch means a specific quantity of Product that is intended to be of uniform character and quality, within specified limits, and is produced during the same cycle of Manufacture as defined by the applicable Batch Record.

  • Demonstration project means one of the following projects:

  • Open type traction battery means a type of battery requiring liquid and generating hydrogen gas released to the atmosphere.

  • 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.

  • Goods Specification means any specification for the Goods, including any related plans and drawings that is set out in the Purchase Order or otherwise agreed in writing by the Customer and the Supplier;

  • Drug test means a test designed to detect the illegal use of a controlled substance.

  • Test means such test as is prescribed by the particulars or considered necessary by the Inspecting Officer whether performed or made by the Inspecting Officer or any agency acting under the direction of the Inspecting Officer;

  • Locational Deliverability Area Reliability Requirement means the projected internal capacity in the Locational Deliverability Area plus the Capacity Emergency Transfer Objective for the Delivery Year, as determined by the Office of the Interconnection in connection with preparation of the Regional Transmission Expansion Plan, less the minimum internal resources required for all FRR Entities in such Locational Deliverability Area.

  • 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.

  • Drug use test means a scientifically substantiated method to test for the presence of illegal or performance-enhancing drugs or the metabolites thereof in a person’s urine.

  • Direction-indicator lamp means the lamp used to indicate to other road-users that the driver intends to change direction to the right or to the left;

  • 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.

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

  • Operational Acceptance Tests means the tests specified in the Technical Requirements and Agreed Project Plan to be carried out to ascertain whether the System, or a specified Sub system, is able to attain the functional and performance requirements specified in the Technical Requirements and Agreed Project Plan, in accordance with the provisions of GCC Clause 27.2 (Operational Acceptance Test).

  • Service Specification means and include detailed description, statements to technical data, performance characteristics, and standards (Indian as well as) as applicable and as specified in the Contract as well as those specifications relating to Industry standards and codes applicable to the performance of the work, work performance quality and the specifications affecting the works or any additional specification required to be produced by the DCO to meet the design criteria.

  • RDDS test Means one query sent to a particular “IP address” of one of the servers of one of the RDDS services. Queries shall be about existing objects in the Registry System and the responses must contain the corresponding information otherwise the query will be considered unanswered. Queries with an RTT 5 times higher than the corresponding SLR will be considered as unanswered. The possible results to an RDDS test are: a number in milliseconds corresponding to the RTT or undefined/unanswered.

  • Nonconforming sign means a sign or sign structure, other than a nonstandard sign or a sign that is erected and maintained in a business area along a scenic byway prior to the designation as a scenic byway, that satisfies 1 of the following:

  • Disinfection profile means a summary of daily Giardia lamblia inactivation through the treatment plant. The procedure for developing a disinfection profile is contained in s. NR 810.34.

  • 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;

  • Brand Name Specification means a specification limited to one or more items by manufacturers’ names or catalogue number.

  • Sample means urine, blood, breath, saliva, or hair.

  • Shipment means a volume of products offered to and accepted by Carrier for transportation.

  • Screening Test means a drug or alcohol test which uses a method of analysis allowed by the Minnesota Drug and Alcohol Testing in the Workplace Act to be used for such purposes.

  • Web Site Accessibility Standards/Specifications means standards contained in Title 1 Texas Administrative Code Chapter 206.

  • Web Site Accessibility Standards/Specifications means standards contained in Title 1 Texas Administrative Code Chapter 206.