engineering-run (non-GMP)

German translation: Testdurchlauf (nicht nach GMP)

GLOSSARY ENTRY (DERIVED FROM QUESTION BELOW)
English term or phrase:engineering-run (non-GMP)
German translation:Testdurchlauf (nicht nach GMP)
Entered by: Harald Moelzer (medical-translator)

14:04 Apr 16, 2020
English to German translations [PRO]
Medical - Medical: Pharmaceuticals / Arzneimittel/Wirkstoff
English term or phrase: engineering-run (non-GMP)
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)
Heike Thomas
Local time: 02:06
Test(durch)lauf
Explanation:

… 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)"
Selected response from:

Harald Moelzer (medical-translator)
Germany
Local time: 02:06
Grading comment
Besten Dank für die Unterstützung!
4 KudoZ points were awarded for this answer



Summary of answers provided
4 +1Test(durch)lauf
Harald Moelzer (medical-translator)


  

Answers


38 mins   confidence: Answerer confidence 4/5Answerer confidence 4/5 peer agreement (net): +1
engineering-run (non-gmp)
Test(durch)lauf


Explanation:

… 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...

--------------------------------------------------
Note added at 39 Min. (2020-04-16 14:44:04 GMT)
--------------------------------------------------


non-GMP bedeutet, dass dieser Produktionstestlauf die GMP-Kriterien noch nicht erfüllt.

--------------------------------------------------
Note added at 15 Stunden (2020-04-17 05:56:53 GMT)
--------------------------------------------------

Zusammen also:
"Testdurchlauf (nicht nach GMP)"

Harald Moelzer (medical-translator)
Germany
Local time: 02:06
Meets criteria
Specializes in field
Native speaker of: Native in GermanGerman
PRO pts in category: 676
Grading comment
Besten Dank für die Unterstützung!

Peer comments on this answer (and responses from the answerer)
agree  Steffen Walter
17 hrs
  -> Danke, Steffen :)
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