Aug 28, 2014 19:23
9 yrs ago
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English term
Argentina
scale-up batch
English to Spanish
Medical
Medical (general)
Medical
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."
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."
Proposed translations
(Spanish)
| 3 | lote de producción acelerada |
Hardy Moreno
|
Proposed translations
57 mins
Hardy Moreno
Native in English
&
Spanish
Works in field
Utmost accuracy and fidelity on time.
Native in: English 
, Spanish
Works in: English to Spanish, Spanish to English
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Reference comments
1 day 7 hrs
Reference:
Findings
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...
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...
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