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.