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  3. Medical: Pharmaceuticals

Harvest

German translation: Ernte

GLOSSARY ENTRY (DERIVED FROM QUESTION BELOW)
English term or phrase:Harvest
German translation:Ernte
Entered by: Roman Lutz

14:09 Dec 10, 2015
English to German translations [PRO]
Medical - Medical: Pharmaceuticals
English term or phrase: Harvest
Ablehnung eines Antrags auf Zulassung eines Arzneimittels;

Es werden die Gründe erläutert, wobei es um Mängel beim Herstellungsprozess geht.

"Reprocessing of undefined, not-complying RP-HPLC side-fractions, blending and homogenisation of batches are not acceptable and need to be removed from the process and the dossier.
The second unresolved major objection is in relation to process validation. Process validation data have been provided from a manufacturing process, which has not been clearly identified and documented. Prospective process validation data only cover the upstream process but do not include operational parameters for fermentation, **harvest** and recovery. Retrospective process validation data for the processes performed in 2005 and 2008/2009 are considered insufficient to reflect splitting , pooling and blending of the maximum defined batches and batch traceability as proposed for the commercial process. "

Bei "Recovery" meine ich, dass es um "Wiederfindung" im analytischen Sinne geht, also denke ich, dass "harvest" terminologietechnisch auch der Analytik zuzuordnen ist, will aber andere Bedeutungen nicht ausschließen.

Vielen Dank im Voraus!
Roman Lutz
Germany
Local time: 02:40
Ernte
Explanation:
"Recovery" dürfe "Ausbeute" sein; https://books.google.de/books?id=V_r1BQAAQBAJ&pg=PA136&lpg=P...
Selected response from:

Susanne Schiewe
Germany
Local time: 02:40
Grading comment
Vielen Dank, hat mir sehr geholfen!
4 KudoZ points were awarded for this answer



Summary of answers provided
3 +2Ernte
Susanne Schiewe
1Ertrag
Regina Eichstaedter


  

Answers


11 mins   confidence: Answerer confidence 1/5Answerer confidence 1/5
harvest
Ertrag


Explanation:
Nur eine Vermutung: Es wird bemängelt, dass diese betriebsspezifischen Aspekte nicht berücksichtigt werden - Fermentierung, Ertrag und Rückgewinnung...

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Note added at 13 mins (2015-12-10 14:22:20 GMT)
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leider keine Zeit zum Überprüfen...

Regina Eichstaedter
Local time: 02:40
Works in field
Native speaker of: Native in GermanGerman
PRO pts in category: 137
Login to enter a peer comment (or grade)

2 hrs   confidence: Answerer confidence 3/5Answerer confidence 3/5 peer agreement (net): +2
harvest
Ernte


Explanation:
"Recovery" dürfe "Ausbeute" sein; https://books.google.de/books?id=V_r1BQAAQBAJ&pg=PA136&lpg=P...

Susanne Schiewe
Germany
Local time: 02:40
Specializes in field
Native speaker of: German
PRO pts in category: 295
Grading comment
Vielen Dank, hat mir sehr geholfen!

Peer comments on this answer (and responses from the answerer)
agree  Dr. Matthias Schauen
17 hrs
agree  Ulrike Eschner
3 days 19 hrs
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