Glossary entry (derived from question below)
English term or phrase:
engineering-run (non-GMP)
German translation:
Testdurchlauf (nicht nach GMP)
Added to glossary by
Harald Moelzer (medical-translator)
Apr 16, 2020 14:04
4 yrs ago
27 viewers *
English term
engineering-run (non-GMP)
English to German
Medical
Medical: Pharmaceuticals
Arzneimittel/Wirkstoff
Es geht eigentlich um die Berechnung von Umsatzsteuer in einer Rechnung, die angefochten wird. Bei der Aufzählung der Prdoukte, die geliefert werden oder Leistungen, die erbracht werden, geht es jedoch um Materialien für eine Research Cell Bank:
Transfer and establishment of analytical methods for IPC (In-process Controls) and release testing of the protein product
9. Qualification of analytical methods (early validation) for Phase l/ll Accuracy, Repeatability, Linearity, Specificity
10. Engineering-run (non-GMP)
Transfer and establishment of analytical methods for IPC (In-process Controls) and release testing of the protein product
9. Qualification of analytical methods (early validation) for Phase l/ll Accuracy, Repeatability, Linearity, Specificity
10. Engineering-run (non-GMP)
Proposed translations
(German)
| 4 +1 | Test(durch)lauf |
Harald Moelzer (medical-translator)
|
Change log
Apr 22, 2020 08:02: Harald Moelzer (medical-translator) changed "Edited KOG entry" from "<a href="/profile/647214">Heike Thomas's</a> old entry - "engineering-run (non-GMP)"" to ""Test(durch)lauf""
Proposed translations
+1
38 mins
Harald Moelzer (medical-translator)
Germany
Germany
Native in German
Specializes in field
Germany
Harald Moelzer (medical-translator) 
medical-translator ...the right words!
Native in: German 
Works in: English to German, German to English, French to German, and 1 more.
Related KudoZ points
:
676
Selected
Test(durch)lauf
… oder "technischer Test(durch)lauf"
"1.25 “Engineering Run” means a Run used for process demonstration and engineering of some or all of the Manufacturing Process steps..."
https://www.sec.gov/Archives/edgar/data/1290157/000119312508...
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Note added at 39 Min. (2020-04-16 14:44:04 GMT)
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non-GMP bedeutet, dass dieser Produktionstestlauf die GMP-Kriterien noch nicht erfüllt.
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Note added at 15 Stunden (2020-04-17 05:56:53 GMT)
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Zusammen also:
"Testdurchlauf (nicht nach GMP)"
4 KudoZ points awarded for this answer.
Comment: "Besten Dank für die Unterstützung!"
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