run away from target

Russian translation: с отклонением от номинальных производственных параметров

17:19 Feb 5, 2020
English to Russian translations [PRO]
Medical - Medical: Pharmaceuticals / GMP, валидация
English term or phrase: run away from target
Table 3.2:
Stage 1 Batch Selection Risk Assessment Tool (e.g., for human solid dosage form) (continued)
Are the process parameters within the established commercial NORs?
• Case 1 = Batch run at nominal process conditions
• Case 2 = Batch **was run away from target** but within established NOR
• Case 3 = Batch or portion was run outside the established NOR
Serhiy
Local time: 01:38
Russian translation:с отклонением от номинальных производственных параметров
Explanation:
https://www.ema.europa.eu/en/documents/scientific-guideline/...
The NOR describes a region around the target operating conditions that contain common operational
variability (variability that can’t always be controlled).

т.е. target operating conditions = nominal process conditions
Selected response from:

hawkwind
Russian Federation
Local time: 09:38
Grading comment
4 KudoZ points were awarded for this answer



Summary of answers provided
4испытанная
Marlin31
3с отклонением от номинальных производственных параметров
hawkwind
3с отклонениями от целевых показателей
Pavel Altukhov


Discussion entries: 1





  

Answers


38 mins   confidence: Answerer confidence 3/5Answerer confidence 3/5
с отклонениями от целевых показателей


Explanation:
n/a

Pavel Altukhov
Local time: 02:38
Native speaker of: Native in RussianRussian
PRO pts in category: 32
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18 hrs   confidence: Answerer confidence 3/5Answerer confidence 3/5
с отклонением от номинальных производственных параметров


Explanation:
https://www.ema.europa.eu/en/documents/scientific-guideline/...
The NOR describes a region around the target operating conditions that contain common operational
variability (variability that can’t always be controlled).

т.е. target operating conditions = nominal process conditions

hawkwind
Russian Federation
Local time: 09:38
Native speaker of: Native in RussianRussian
PRO pts in category: 274
Login to enter a peer comment (or grade)

22 hrs   confidence: Answerer confidence 4/5Answerer confidence 4/5
испытанная


Explanation:
серия, испытанная при...

Marlin31
Russian Federation
Local time: 02:38
Specializes in field
Native speaker of: Native in RussianRussian
PRO pts in category: 268
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