consistency batches

Russian translation: установочные серии

18:56 Jul 5, 2020
English to Russian translations [PRO]
Medical - Medical: Pharmaceuticals / module 3 - quality
English term or phrase: consistency batches
The acceptance criteria are based on the statistical tool of mean ± 3 standard deviations (SD) from release, in-process, real time stability, and End of Shelf Life (EoSL) data from consistency and clinical batches of the drug substance.
Artyom Timeyev
Russian Federation
Local time: 05:45
Russian translation:установочные серии
Explanation:
Другой вариант названия - conformance lots. Согласно требованиям FDA, нужно три серии продукта, согласно EMEA - пять для подтверждения воспроизводимости получаемого продукта.

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Note added at 22 mins (2020-07-05 19:18:55 GMT)
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О проверке воспроизводимости производственного процесса можно прочесть все там же - https://bit.ly/3e29NQ3
Selected response from:

Natalie
Poland
Local time: 02:45
Grading comment
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4 KudoZ points were awarded for this answer



Summary of answers provided
4установочные серии
Natalie
4установочные партии
Oleg Shumilov


  

Answers


19 mins   confidence: Answerer confidence 4/5Answerer confidence 4/5
установочные серии


Explanation:
Другой вариант названия - conformance lots. Согласно требованиям FDA, нужно три серии продукта, согласно EMEA - пять для подтверждения воспроизводимости получаемого продукта.

--------------------------------------------------
Note added at 22 mins (2020-07-05 19:18:55 GMT)
--------------------------------------------------

О проверке воспроизводимости производственного процесса можно прочесть все там же - https://bit.ly/3e29NQ3

Natalie
Poland
Local time: 02:45
Specializes in field
Native speaker of: Russian
PRO pts in category: 13399
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1 day 20 hrs   confidence: Answerer confidence 4/5Answerer confidence 4/5
установочные партии


Explanation:
...

Oleg Shumilov
Russian Federation
Local time: 03:45
Specializes in field
Native speaker of: Russian
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