Glossary entry

Russian term or phrase:

о соответствии производителя лекарственного препарата

English translation:

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

Added to glossary by Ellen Kraus
Sep 6, 2016 16:55
7 yrs ago
1 viewer *
Russian term

о соответствии производителя лекарственного препарата

Russian to English Medical Medical: Pharmaceuticals
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.
Change log

Sep 23, 2016 16:02: Ellen Kraus Created KOG entry

Proposed translations

+1
24 mins
Selected

the drug producer´s compliance with the guidelines of GMP (Good Manufacturing Practices )

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.

Peer comment(s):

agree Evgeni Kushch : better manufacturer
1 day 16 hrs
Thank you, Evgeni !
Something went wrong...
4 KudoZ points awarded for this answer.
+3
8 mins

Drug manufacturer's GMP Certificate

Drug manufacturer's GMP Certificate issued by....
you may add Compliance, as in
Drug manufacturer's GMP Compliance Certificate
Peer comment(s):

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
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