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 A.Efremova

link 9.10.2018 10:02 
Subject: Определение GMP pharma.
Добрый день!

Возникли сложности с переводом данного отрывка из Договора об обеспечении качества при поставке субстанции:

cGMP shall mean the (current) Good Manufacturing Practices in accordance with WHO Good Manufacturing Practices, EC Guide to Good Manufacturing Practice for Medicinal Contract Products for Human and Veterinary Use (European Community Directive 2003/94/EC as amended) Part II (Reference to ICH Q7), current Good Manufacturing Practice regulations for Drugs, Finished Pharmaceuticals and Medical Devices (21 CFR Parts 210, 211, 820), USA as all of such regulations, guidelines and directives may be updated or amended from time to time, other comparable regulatory standards, in each case including those procedures expressed or implied in the regulatory documents with respect to the SUBSTANCE provided to regulatory authorities and as applicable to the manufacture of SUBSTANCE, as such regulations are in effect at the time of manufacturing the SUBSTANCE.

Не понятна вторая часть предложения, начиная с as all of such regulations...

Буду очень признательна за помощь. Спасибо.

 Yippie

link 9.10.2018 10:21 
Смысл: все правила и регулировки постоянно корректируются, поэтому применяться будут те, которые действуют на момент производства

 

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