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19:23 Aug 28, 2014
English to Spanish translations [PRO] Medical - Medical (general) / Medical
English term or phrase:scale-up batch
What is the equivalent of "scale-up batch in this sentence, talking about a drug batch.
"The classification of the scale-up batch that the whole process is regarded as non critical has been confirmed by the validation batches."
Reference information: CHANGES IN BATCH SIZE (SCALE-UP/SCALE-DOWN)
Postapproval changes in the size of a batch from the pivotal/pilot scale biobatch
material to larger or smaller production batches call for submission of additional
information in the application. Scale-down below 100,000 dosage units is not
covered by this guidance. All scale-up changes should be properly validated
and, where needed, inspected by appropriate agency personnel.
A specific quantity of a drug or other material produced according to a
single manufacturing order during the same cycle of manufacture and
intended to have uniform character and quality, within specified limits [21
The process of increasing the batch size. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulat...
lorenab23 United States Specializes in field Native speaker of: English, Spanish PRO pts in category: 204