maintain the status

Russian translation: *

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 KudoZ activity Questions: 8836 (2 open) (1 without valid answers) (739 closed without grading) Answers: 43
Local time: 17:07

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: 00:07

Grading comment

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4 KudoZ points were awarded for this answer

Summary of answers provided

3 +2

hawkwind

для поддержания состояния

Viktor Kovalchuk

Answers

41 mins confidence:

для поддержания состояния

Explanation:
для поддержания (рабочего) состояния

Viktor Kovalchuk
Local time: 17:07
Native speaker of:

Russian,

Ukrainian
PRO pts in category: 20

3 hrs confidence:

peer agreement (net): +2

hawkwind
Russian Federation
Local time: 00:07
Specializes in field
Native speaker of:

Russian
PRO pts in category: 498

Grading comment

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