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  3. Medical: Pharmaceuticals

continued induced input variability

Russian translation: *

07:05 Feb 5, 2020
English to Russian translations [PRO]
Medical - Medical: Pharmaceuticals / GMP, валидация
English term or phrase: continued induced input variability
This information contributes to understanding the process and control strategy and allows decisions to be made in terms of residual risk prior to PPQ and/or the need for continued input variability assessment in the later PV stages.
For example, a parameter that is particularly critical or more directly impacts a critical drug product attribute may require **continued induced input variability** in order to gain needed experience and confidence.
Serhiy
Local time: 23:12
Russian translation:*
Explanation:
имитационное внесение (моделирование) на постоянной основе (предельных) изменений критических входных параметров
http://biofermenter.ru/validaciya-processov-novyy-podhod-fda
Цель квалификации процесса состоит в том, чтобы показать, что процесс способен обеспечить устойчивое коммерческое производство, т.е. готов гарантировать качество продукта, несмотря на любую изменчивость характеристик сырья и материалов, а также технологических показателей процесса.
https://www.fda.gov/media/71021/download
Other activities, such as experiments or demonstrations at laboratory or pilot scale, also assist in
evaluation of certain conditions and prediction of performance of the commercial process. These
activities also provide information that can be used to model or simulate the commercial process.
Computer-based or virtual simulations of certain unit operations or dynamics can provide
process understanding and help avoid problems at commercial scale.
...
However, the full spectrum of input variability typical of
commercial production is not generally known at this stage. Laboratory or pilot-scale models
designed to be representative of the commercial process can be used to estimate variability.
Selected response from:

hawkwind
Russian Federation
Local time: 06:12
Grading comment
4 KudoZ points were awarded for this answer



Summary of answers provided
3постоянное изменение вводимых данных новыми, появляющимися в ходе испытаний (лекарственного препарат
Igor Arefyev
3*
hawkwind


  

Answers


5 hrs   confidence: Answerer confidence 3/5Answerer confidence 3/5
постоянное изменение вводимых данных новыми, появляющимися в ходе испытаний (лекарственного препарат


Explanation:
-

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Note added at 5 hrs (2020-02-05 12:21:42 GMT)
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препарата

Igor Arefyev
Russian Federation
Local time: 23:12
Native speaker of: Russian
PRO pts in category: 36
Login to enter a peer comment (or grade)

18 hrs   confidence: Answerer confidence 3/5Answerer confidence 3/5
*


Explanation:
имитационное внесение (моделирование) на постоянной основе (предельных) изменений критических входных параметров
http://biofermenter.ru/validaciya-processov-novyy-podhod-fda
Цель квалификации процесса состоит в том, чтобы показать, что процесс способен обеспечить устойчивое коммерческое производство, т.е. готов гарантировать качество продукта, несмотря на любую изменчивость характеристик сырья и материалов, а также технологических показателей процесса.
https://www.fda.gov/media/71021/download
Other activities, such as experiments or demonstrations at laboratory or pilot scale, also assist in
evaluation of certain conditions and prediction of performance of the commercial process. These
activities also provide information that can be used to model or simulate the commercial process.
Computer-based or virtual simulations of certain unit operations or dynamics can provide
process understanding and help avoid problems at commercial scale.
...
However, the full spectrum of input variability typical of
commercial production is not generally known at this stage. Laboratory or pilot-scale models
designed to be representative of the commercial process can be used to estimate variability.

hawkwind
Russian Federation
Local time: 06:12
Specializes in field
Native speaker of: Native in RussianRussian
PRO pts in category: 498
Login to enter a peer comment (or grade)



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