Apr 10, 2016 11:46
8 yrs ago
3 viewers *
English term
\"if tested\" specification
English to Russian
Medical
Medical: Pharmaceuticals
Manufacturing process for tablets
Сноски в спецификации (раздел "микробиологическая чистота"):
Microbial contamination
- Total viable aerobic count
- bacteria
- fungi
- E. coli
- Enterobacteria1
- Salmonella2
1 Enterobacteria only as ‘if tested’ specification
2 Salmonella only as ‘if tested’ specification
Microbial contamination
- Total viable aerobic count
- bacteria
- fungi
- E. coli
- Enterobacteria1
- Salmonella2
1 Enterobacteria only as ‘if tested’ specification
2 Salmonella only as ‘if tested’ specification
Proposed translations
(Russian)
| 4 | спецификация "при необходимости испытания" |
Natalie
|
Proposed translations
2 hrs
Selected
спецификация "при необходимости испытания"
Мне встречалась какая-то конкретная формулировка. А смысл - вот в чем:
It is possible that, in addition to release tests, a specification may list in-process tests as defined in 2.3, periodic (skip) tests, and other tests which are not always conducted on a batch-by-batch basis. In such cases the applicant should specify which tests are routinely conducted batch-by-batch, and which tests are not, with an indication and justification of the actual testing frequency. In this situation, the drug substance and / or drug product should meet the acceptance criteria if tested.
http://tinyurl.com/z38khfc
It is possible that, in addition to release tests, a specification may list in-process tests as defined in 2.3, periodic (skip) tests, and other tests which are not always conducted on a batch-by-batch basis. In such cases the applicant should specify which tests are routinely conducted batch-by-batch, and which tests are not, with an indication and justification of the actual testing frequency. In this situation, the drug substance and / or drug product should meet the acceptance criteria if tested.
http://tinyurl.com/z38khfc
4 KudoZ points awarded for this answer.
Comment: "Спасибо, Наташа."
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