This site uses cookies. Some of these cookies are essential to the operation of the site, while others help to improve your experience by providing insights into how the site is being used. For more information, please see the ProZ.com privacy policy.
Cookie settings
  1. KudoZ™ Top
  2. Russian to English
  3. Medical: Pharmaceuticals

нормативный документ по качеству

English translation: regulations on quality

GLOSSARY ENTRY (DERIVED FROM QUESTION BELOW)
Russian term or phrase:нормативный документ по качеству
English translation:regulations on quality
Entered by: Oleg Lozinskiy

10:33 Apr 8, 2020
Russian to English translations [PRO]
Medical - Medical: Pharmaceuticals / Eurasian Union
Russian term or phrase: нормативный документ по качеству
В регистрационных досье на лекарственные препараты, заявления о регистрации которых поданы по процедуре взаимного признания или децентрализованной процедуре, после 22.03.2020, проект нормативного документа по качеству должен быть представлен в Модуле 1 регистрационного досье:
Artyom Timeyev
Russian Federation
Local time: 17:09
regulations on quality
Explanation:
*
Selected response from:

Oleg Lozinskiy
Russian Federation
Local time: 15:09
Grading comment
Selected automatically based on peer agreement.
4 KudoZ points were awarded for this answer



Summary of answers provided
3 +2regulations on quality
Oleg Lozinskiy
4 +1Quality Requirements Document
interprivate
5regulatory quality document
IrinaN
3 +1normative document on quality (indicators and quality control methods)
Frank Szmulowicz, Ph. D.
3draft quality specifications
Pavel Altukhov
Summary of reference entries provided
quality control documents
Turdimurod Rakhmanov

  

Answers


9 mins   confidence: Answerer confidence 3/5Answerer confidence 3/5 peer agreement (net): +2
regulations on quality


Explanation:
*

Oleg Lozinskiy
Russian Federation
Local time: 15:09
Native speaker of: Native in RussianRussian
PRO pts in category: 131
Grading comment
Selected automatically based on peer agreement.

Peer comments on this answer (and responses from the answerer)
agree  Turdimurod Rakhmanov
1 hr
  -> Thank you, Turdimurod!
agree  Irina Kuzminskaya
8 hrs
  -> Thank you, Irina!
Login to enter a peer comment (or grade)

1 hr   confidence: Answerer confidence 3/5Answerer confidence 3/5
draft quality specifications


Explanation:
n/a

Pavel Altukhov
Local time: 15:09
Native speaker of: Russian
PRO pts in category: 28
Login to enter a peer comment (or grade)

1 hr   confidence: Answerer confidence 4/5Answerer confidence 4/5 peer agreement (net): +1
Quality Requirements Document


Explanation:
ttps://www.modernanalyst.com/Resources/Articles/tabid/115/ID/5464/...
9 Types Of Requirements Documents: What They Mean And Who Writes Them
...
7. Quality Requirements Document
The quality requirements document outlines the expectations of the customer for the quality of the final product. It consists of various criteria, factors and metrics that must be satisfied.
Quality requirements might revolve around reliability, consistency, availability, usability, maintainability and customer experience.


--------------------------------------------------
Note added at 1 hr (2020-04-08 12:03:42 GMT)
--------------------------------------------------

https://www.google.com/search?client=ms-android-xiaomi&sxsrf...

interprivate
Local time: 13:09
Native speaker of: Native in RussianRussian, Native in UkrainianUkrainian
PRO pts in category: 76

Peer comments on this answer (and responses from the answerer)
agree  Turdimurod Rakhmanov
40 mins
  -> Thank you!
Login to enter a peer comment (or grade)

1 hr   confidence: Answerer confidence 3/5Answerer confidence 3/5 peer agreement (net): +1
normative document on quality (indicators and quality control methods)


Explanation:
20) normative documentation is a document containing a list of quality indicators and quality
control methods for a medicine for medical use as determined under the relevant expert examination
results, established by the manufacturer;
21) normative document is a document containing a list of quality indicators and (or) quality
control methods for a pharmaceutical form as determined under the relevant expert examination
results, description of biological, biochemical, microbiological, physicochemical, physical, chemical and
other methods of analysis of medicines for veterinary use and requirements to the reagents, titrated
solutions and indicators used for t
http://ascentcrs.com/images/documents/Circulation of Medicin... purpose of such analysis, established by the manufacturer;


cccccc
Quality of medicinal products: relationship between normative document and specification, application dossier, pharmacopoeia, and GMP.
http://csa.expert/2017/07/12/quality-of-medicinal-products-r...
ccccccccccccc

A normative document might describe different speed limits in differing areas and why it is better to slow down around schools and in neighborhoods. The regulatory document (otherwise known as 'the law') would describe who might enforce speed limits and what happens when someone is caught speeding.
https://ell.stackexchange.com/questions/111963/are-normative...

Frank Szmulowicz, Ph. D.
United States
Local time: 08:09
Works in field
Native speaker of: Native in EnglishEnglish, Native in PolishPolish
PRO pts in category: 282

Peer comments on this answer (and responses from the answerer)
agree  Turdimurod Rakhmanov
16 mins
  -> Thank you,Turdimurod. Take care!
neutral  IrinaN: SOrry, Frank but "normative" in your ref. leads directly to another Russian invention.
11 hrs
  -> I wish there was one Russian counterexample. As I could not find one, I had to assume that normative as used by the specialists corresponds to the Russian term. The English use of normative confirms that: https://www.thefreedictionary.com/normative.
Login to enter a peer comment (or grade)

13 hrs   confidence: Answerer confidence 5/5
regulatory quality document


Explanation:
Есть готовый и очевидный термин.


http://www.eurasiancommission.org/en/act/texnreg/deptexreg/L...
Manual for
compilation of a regulatory quality document approved by the Eurasian
Economic Commission (hereinafter the Commission)

IrinaN
United States
Local time: 07:09
Native speaker of: Native in RussianRussian
PRO pts in category: 20
Login to enter a peer comment (or grade)




Reference comments


2 hrs
Reference: quality control documents

Reference information:
Как вариант,
ответы уже есть.

Turdimurod Rakhmanov
Kyrgyzstan
Specializes in field
Native speaker of: Native in UzbekUzbek, Native in KirghizKirghiz
PRO pts in category: 44
Login to enter a peer comment (or grade)



Login or register (free and only takes a few minutes) to participate in this question.

You will also have access to many other tools and opportunities designed for those who have language-related jobs (or are passionate about them). Participation is free and the site has a strict confidentiality policy.

Return to KudoZ list

KudoZ™ translation help

The KudoZ network provides a framework for translators and others to assist each other with translations or explanations of terms and short phrases.

See also:
ProZ.com term search
Search millions of term translations
Close search
Term search
  • All of ProZ.com
  • Term search
  • Jobs
  • Forums
  • Multiple search