ICH Richtlinien WA

01:50 Jul 23, 2016
This question was closed without grading. Reason: Other

German to English translations [PRO]
Medical - Medical: Pharmaceuticals / ICH Richtlinien
German term or phrase: ICH Richtlinien WA
What doses abbreviation WA stand for? Wirksamkeit?
Background : new regulations for active substances and additives
Julia_Z
China
Local time: 02:00


Summary of answers provided
4 +1ICH/GMP guidelines for...
Harald Moelzer (medical-translator)
4Wertanalyse
Erzsébet Czopyk


Discussion entries: 1





  

Answers


5 hrs   confidence: Answerer confidence 4/5Answerer confidence 4/5
Wertanalyse


Explanation:
https://books.google.hu/books?id=jtEjBgAAQBAJ&pg=PA154&lpg=P...

Seite 152-154

Erzsébet Czopyk
Hungary
Local time: 20:00
Specializes in field
Native speaker of: Native in HungarianHungarian
PRO pts in category: 4

Peer comments on this answer (and responses from the answerer)
neutral  Cilian O'Tuama: You seem to have misread the Q.
15 hrs
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8 hrs   confidence: Answerer confidence 4/5Answerer confidence 4/5 peer agreement (net): +1
ICH/GMP guidelines for...


Explanation:

...manufacturers of active substances and medicines (Wirkstoffhersteller und Arzneimittelhersteller)

"Der EU-GMP-Leitfaden Teil II „Mindestanforderungen für Wirkstoffe, die als Arzneimittel eingesetzt werden“... Somit ist der Leitfaden unverzichtbar für Wirkstoffhersteller und Arzneimittelhersteller, die die Qualität der eingesetzten Wirkstoffe garantieren müssen..."
https://www.gmp-verlag.de/de/gmp-gesetze-ich/gmp-wirkstoffe....
https://de.wikipedia.org/wiki/Gute_Herstellungspraxis

Given your context, another option would be "active substances and additives" (Wirkstoffe und Additive), see:
"GMP für Wirk- und Hilfsstoffe in der Pharmaindustrie..."
https://www.gmp-verlag.de/de/gmp-paperback/gmp-fuer-wirk-und...



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Note added at 18 Tage (2016-08-10 09:11:43 GMT)
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How did you finally solve this - is it possible to get some feedback?

Harald Moelzer (medical-translator)
Germany
Local time: 20:00
Specializes in field
Native speaker of: Native in GermanGerman
PRO pts in category: 317
Notes to answerer
Asker: Thank you very much for your answer. I am still not sure about the meaning of WA in " ICH Richtlinien WA". It's an English > Chinese translation doc which have been translated from German and there is no meaningful context. So I kept “WA”.

Asker: Full paragraph for reference: “Medicinal products as well as active substances and additives are also subject to GMP regulations as defined by 21 CFR parts *** and *** of the US Code of Federal Regulation and other European regulations and guidelines. The new regulations for active substances and additives have been mean while put into force (ICH Guide WA).”


Peer comments on this answer (and responses from the answerer)
agree  Cilian O'Tuama: (vielleicht ingredients anstatt substances)
13 hrs
  -> Many thanks, Cilian!
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