maintain the status

Russian translation: *

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07:04 May 23, 2018
English to Russian translations [PRO]
Medical - Medical: Pharmaceuticals
English term or phrase: maintain the status
The qualification of recipients including specifying requirements for this qualification is not within the responsibility of the manufacturing site, for two reasons: a) goods are not owned by the mfg site, and b) mfg sites do not manage transportation.
In addition, during room qualification the frequency of walk throughs by the person responsible for the room will be determined to maintain the status.
In the qualification documentation for the climatic chamber installed in room C-01-10 the limit values for temperature (± 3 °C instead of ± 2 °C) according to ICH Q1A(R) were not indicated correctly and the reference was missing as well.
Maxim Polukhin
Local time: 03:29
Russian translation:*
Explanation:
поддерживание статуса квалификации помещения
http://www.gmpua.com/World/Manu/06/h.htm
6.H.2 Requalification

The term requalification covers several aspects. This can be the regular requalification of facilities, requalification of an already qualified facility after significant changes and maintenance of the qualified status.

8.6.1 Общие положения
https://allgosts.ru/03/120/gost_r_iso_15378-2017
Должна поддерживаться верификация/квалификация оборудования и валидация процессов/продукции. Любые изменения должны быть оценены с точки зрения риска их влияния на статус валидации. При необходимости следует провести надлежащую верификацию/квалификацию/валидацию или повторную квалификацию/ валидацию.
Selected response from:

hawkwind
Russian Federation
Local time: 10:29
Grading comment
Спасибо!
4 KudoZ points were awarded for this answer



Summary of answers provided
3 +1*
hawkwind
2для поддержания состояния
Віктор Коваль


  

Answers


41 mins   confidence: Answerer confidence 2/5Answerer confidence 2/5
для поддержания состояния


Explanation:
для поддержания (рабочего) состояния

Віктор Коваль
Local time: 03:29
Native speaker of: Native in RussianRussian, Native in UkrainianUkrainian
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3 hrs   confidence: Answerer confidence 3/5Answerer confidence 3/5 peer agreement (net): +1
*


Explanation:
поддерживание статуса квалификации помещения
http://www.gmpua.com/World/Manu/06/h.htm
6.H.2 Requalification

The term requalification covers several aspects. This can be the regular requalification of facilities, requalification of an already qualified facility after significant changes and maintenance of the qualified status.

8.6.1 Общие положения
https://allgosts.ru/03/120/gost_r_iso_15378-2017
Должна поддерживаться верификация/квалификация оборудования и валидация процессов/продукции. Любые изменения должны быть оценены с точки зрения риска их влияния на статус валидации. При необходимости следует провести надлежащую верификацию/квалификацию/валидацию или повторную квалификацию/ валидацию.

hawkwind
Russian Federation
Local time: 10:29
Native speaker of: Native in RussianRussian
PRO pts in category: 151
Grading comment
Спасибо!

Peer comments on this answer (and responses from the answerer)
agree  Igor Andreev
1 hr
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