Technical Batch definition

Technical Batch means a Batch that is intended to demonstrate the transfer of the Manufacturing Process to the Facility.
Technical Batch means, with respect to a Batch, that such Batch is Manufactured as a technical trial run and any resulting BDS may not meet the BDS Specifications.
Technical Batch means a non GMP batch with the purpose of providing evidence that a process of a specific batch size delivers a batch of specified quality.

Examples of Technical Batch in a sentence

  • During manufacturing of a Technical Batch, Customer shall be permitted to have [***] at the drug product manufacturing Facility as reasonably requested by Customer, at any time during the Manufacturing Process for the purpose of observing, reporting on, and consulting as to the performance of the Services.

  • During manufacturing of the first Technical Batch, Customer shall be permitted to have [***] at the drug product manufacturing Facility as reasonably requested by Customer, at any time during the Manufacturing Process for the purpose of observing, reporting on, and consulting as to the performance of the Services.

  • For the validation campaign of the Products, Syntagon will produce in 2013 of three (3) Batches of XMeNa and three (3) Batches of 13cis XMeNa of 1100 g (+/-20%), and before the validation campaign, one (1) of each Technical Batch to enable the Process to be validated at this scale.

Related to Technical Batch

  • 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.

  • Technical Bid means the bid submitted online through the electronic bidding platform, containing the documents as listed out in Clause 2.5.2 of this RFP;

  • technical specification means a document that prescribes technical requirements to be fulfilled by a product, process or service;

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

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

  • Product Specifications means those Manufacturing, performance, quality - control release, and Fill/Finish specifications for Drug Substance or Licensed Product in the Territory, which are initially as set forth in the applicable Regulatory Approval for a Licensed Product, as such specifications may be amended from time to time pursuant to the terms of this Agreement.

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

  • Batch Record means the production record pertaining to a Batch.

  • Class specification means a written description of a class setting forth factors and conditions which are essential characteristics of positions in that class.

  • MSAA Indicator Technical Specifications document means, as the context requires, either or both of the document entitled “Multi-Sector Service Accountability Agreement (MSAA) 2019-20 Indicator Technical Specifications November 5, 2018 Version 1.3” and the document entitled “Multi-Sector Service Accountability Agreement (MSAA) 2019-20 Target and Corridor-Setting Guidelines” as they may be amended or replaced from time to time;

  • Manufacturing Process means any process for—

  • API means the American Petroleum Institute.

  • Goods Specification any specification for the Goods including any relevant plans or drawings, that is agreed in writing by the Reseller and Voip-Unlimited.

  • Contract Manufacturer means a company that produces goods under contract for another company under the label or brand name of that company.

  • Finished Product means a cannabis product in its final form to be sold at a retail premises.

  • 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.

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

  • 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.

  • 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.

  • Non-Conforming Product means a Product that does not conform to the Supplier’s Warranties.

  • 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.

  • Contract Specifications means the principal trading terms in CFD (for example Spread, Swaps, Lot Size, Initial Margin, Necessary Margin, Hedged Margin, the minimum level for placing Stop Loss, Take Profit and Limit Orders, financing charges, charges etc) for each type of CFD as determined by the Company from time to time.

  • IS Specification means the Specification of latest edition with amendments, if any, up to time of receipt of tender by Corporation issued by the Bureau of Indian Standards as referred to in the specifications and / or work orders.

  • Purchase Order means the form or format a Customer uses to make a purchase under the Contract (e.g., a formal written purchase order, electronic purchase order, procurement card, contract or other authorized means).

  • 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.

  • Bulk Product means Licensed Product supplied in a form other than Finished Product which can be converted into Finished Product.