scale-up batch

Spanish translation: lote de producción acelerada

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 KudoZ activity Questions: 697 (7 open) (6 without valid answers) (2 closed without grading) Answers: 0 Argentina
Local time: 09:28

Spanish translation:lote de producción acelerada

Explanation:
lote de producción acelerada

Selected response from:

Hardy Moreno
Local time: 07:28

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Summary of answers provided

lote de producción acelerada

Hardy Moreno

Summary of reference entries provided

Findings

lorenab23

Answers

57 mins confidence:

lote de producción acelerada

Explanation:
lote de producción acelerada

Hardy Moreno
Local time: 07:28
Works in field
Native speaker of:

English,

Spanish
PRO pts in category: 15

Grading comment

Thanks!

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:

English,

Spanish
PRO pts in category: 208

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