Technical Batch definition

Technical Batch means a Batch that is intended to demonstrate the transfer of the Manufacturing Process to the Facility.
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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.
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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.
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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 the document referred to in:

  • Technical Specifications A specification in a document defining the characteristics of a product or a service, such as the quality levels, the environmental and climate performance levels, the design for all needs, including accessibility for people with disabilities, and the evaluation of conformity, of product performance, of the use of the product, safety or dimensions, as well as requirements applicable to the product as regards the name by which it is sold, terminology, symbols, testing and test methods, packaging, marking or labelling, instructions for use, the production processes and methods at every stage in the life cycle of the supply or service, as well as the evaluation and conformity procedures;