Glossary entry

English term or phrase:

moderate quality change

Russian translation:

умеренное изменение параметров качества / качественных параметров

Added to glossary by Oleg Lozinskiy
Jan 16, 2021 16:52
3 yrs ago
15 viewers *
English term

moderate quality change

English to Russian Medical Medical: Pharmaceuticals
Moderate quality changes are changes to the product composition, manufacturing process, quality controls, facilities or equipment that have a moderate potential to have an impact on the quality, safety or efficacy of the biotherapeutic product or SBR The marketing authorization holder should submit a PAS and receive a notification of approval from the NRA before implementing the change.
Change log

Mar 26, 2021 09:47: Oleg Lozinskiy Created KOG entry

Proposed translations

+1
5 mins
Selected

умеренное изменение параметров качества / качественных параметров

Peer comment(s):

agree Yulia HERVE
2 days 13 hrs
Thank you, Yulia!
Something went wrong...
4 KudoZ points awarded for this answer.
41 mins

изменения качества лекарства в умеренном диапазоне

Современные фармацевтические препараты, предназначенные для снижения массы
тела, как правило, содержат хром ... показатели шкалы лежат в умеренном диапазоне ...
Something went wrong...
1 hr

умеренные изменения, связанные с качеством

Изменения с умеренной вероятностью влияния на качество.
Something went wrong...
Term search
  • All of ProZ.com
  • Term search
  • Jobs
  • Forums
  • Multiple search