о соответствии производителя лекарственного препарата

English translation: the drug manufacturer´s compliance with the guidelines of GMP (Good Manufacturing Practices )

GLOSSARY ENTRY (DERIVED FROM QUESTION BELOW)
Russian term or phrase:о соответствии производителя лекарственного препарата
English translation:the drug manufacturer´s compliance with the guidelines of GMP (Good Manufacturing Practices )
Entered by: Ellen Kraus

16:55 Sep 6, 2016
Russian to English translations [PRO]
Medical - Medical: Pharmaceuticals
Russian term or phrase: о соответствии производителя лекарственного препарата
Письмо от Спонсора касательно производителя препарата СТ-Р13 для подкожного введения от 29.06.2016 на английском языке; перевод на русский язык от 11.07.2016.
Нотариально заверенная копия заключения от 30.03.2016 о соответствии производителя лекарственного препарата Бинекс Ко., Лтд требованиям правил Надлежащей производственной практики (GMP), выданного компетентным уполномоченным органом страны производителя лекарственного препарата (Республика Корея), на английском языке и его перевод на русский язык.
Anastasia Serdyukova
Russian Federation
Local time: 13:42
the drug producer´s compliance with the guidelines of GMP (Good Manufacturing Practices )
Explanation:
Good manufacturing practices (GMP) are the practices required in order to conform to the guidelines recommended by agencies that control authorization and licensing for manufacture and sale of food, drug products, and active pharmaceutical products. These guidelines provide minimum requirements that a pharmaceutical or a food product manufacturer must meet to assure that the products are of high quality and do not pose any risk to the consumer or public.

Selected response from:

Ellen Kraus
Austria
Local time: 12:42
Grading comment
4 KudoZ points were awarded for this answer



Summary of answers provided
4 +3Drug manufacturer's GMP Certificate
Michael Moskowitz
4 +1the drug producer´s compliance with the guidelines of GMP (Good Manufacturing Practices )
Ellen Kraus


  

Answers


8 mins   confidence: Answerer confidence 4/5Answerer confidence 4/5 peer agreement (net): +3
Drug manufacturer's GMP Certificate


Explanation:
Drug manufacturer's GMP Certificate issued by....
you may add Compliance, as in
Drug manufacturer's GMP Compliance Certificate

Michael Moskowitz
Local time: 06:42
Native speaker of: Native in EnglishEnglish, Native in RussianRussian
PRO pts in category: 15

Peer comments on this answer (and responses from the answerer)
agree  Sofia Gutkin: The last option - Compliance Certificate
3 hrs
  -> Thanks

agree  Ravindra Godbole
7 hrs

agree  Evgeni Kushch: [on] Drug Manufacturer Compliance [with], хотя бы здесь http://www.fda.gov/Drugs/DevelopmentApprovalProcess/Manufact...
1 day 16 hrs
Login to enter a peer comment (or grade)

24 mins   confidence: Answerer confidence 4/5Answerer confidence 4/5 peer agreement (net): +1
the drug producer´s compliance with the guidelines of GMP (Good Manufacturing Practices )


Explanation:
Good manufacturing practices (GMP) are the practices required in order to conform to the guidelines recommended by agencies that control authorization and licensing for manufacture and sale of food, drug products, and active pharmaceutical products. These guidelines provide minimum requirements that a pharmaceutical or a food product manufacturer must meet to assure that the products are of high quality and do not pose any risk to the consumer or public.



Ellen Kraus
Austria
Local time: 12:42
Native speaker of: Native in GermanGerman
PRO pts in category: 28

Peer comments on this answer (and responses from the answerer)
agree  Evgeni Kushch: better manufacturer
1 day 16 hrs
  -> Thank you, Evgeni !
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