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scale-up batch

Spanish translation: lote de producción acelerada

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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
Hello,

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."
Fernanda1984
Argentina
Local time: 11:32
Spanish translation:lote de producción acelerada
Explanation:
lote de producción acelerada
Selected response from:

Hardy Moreno
Local time: 08:32
Grading comment
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4 KudoZ points were awarded for this answer

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Summary of answers provided
3lote de producción acelerada
Hardy Moreno
Summary of reference entries provided
Findings
lorenab23

  

Answers


57 mins   confidence: Answerer confidence 3/5Answerer confidence 3/5
lote de producción acelerada


Explanation:
lote de producción acelerada

Hardy Moreno
Local time: 08:32
Works in field
Native speaker of: Native in EnglishEnglish, Native in SpanishSpanish
PRO pts in category: 15
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Thanks!
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Reference comments


1 day 7 hrs
Reference: Findings

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. Batch
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
CFR 210.3(b)(2)].
O. Scale-up
The process of increasing the batch size.
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulat...

lorenab23
United States
Specializes in field
Native speaker of: Native in EnglishEnglish, Native in SpanishSpanish
PRO pts in category: 204
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