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please help unravel a sentence

English translation: more grist for the mill

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18:52 Jul 8, 2002
German to English translations [PRO]
Tech/Engineering
German term or phrase: please help unravel a sentence
context: pharmaceutical industry - qualification and validation of facilities, systems, equipment, etc. according to the GMP-Guide (Good Manufacturing Practices)

"Bei komplexen Projekten wird ein Validation Master Plan erstellt, in dem die Validierung der einzelnen Untereinheiten einer Anlage bzw. die Versorgungssysteme (Dampf, Druckluft, Wasser, Klima) unter Bezug auf eine entsprechende V-SOP bzw. *eines* Qualifizierungs- oder Validierungsplans und die entsprechenden Annahmekriterien spezifiziert werden und der Umfang der Herzustellenden Validierungschargen definiert wird."

My take is:
The 'Validation Master Plan' specifies:
1) the validation of the individual subunits of the facility (Anlage)

2) the supply systems ...
under reference to a V-SOP

3)the acceptance criteria

and defines the scope/size of the validation batches to be prepared

The genitive case is throwing me off, and I am going in circles with this. How does "eines Qualifizierungs- oder Validierungsplans" fit into this? I would be very grateful if anyone can help poor brain-dead me unravel this sentence.

TIA, Beth
Beth Kantus
United States
Local time: 15:20
English translation:more grist for the mill
Explanation:
the VMP specifies:
a) the validation of the individual subsystems (or subunits if you will) of the facility or of its supply systems, b) the acceptance criteria
c) the scope or extent of the validation batches/lots

- and it does this by/while making reference to a V-SOP or a qualification or validation plan

(in other the words, the latter item(s) are formally & physically separate from the VMP but are identified as reference documents in the VMP and thus logically form part of the VMP (if you follow me).

As far as the 'eines', I agree with the first two answers; it's sloppy writing or sloppy editing.
Selected response from:

Ken Cox
Local time: 21:20
Grading comment

Thanks to you all for helping me sort this one out!
4 KudoZ points were awarded for this answer

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Summary of answers provided
4 +1please don't think it's serious...Ulla Haufe
4 +1IF
Elisabeth Ghysels
4more grist for the millKen Cox
4sentencegangels


  

Answers


20 mins   confidence: Answerer confidence 4/5Answerer confidence 4/5 peer agreement (net): +1
please don't think it's serious...


Explanation:
never assume, that those people are gramatically right (e.g. see herzustellenden with a capital letter)
unter Bezug auf is followed by two parts
einer V-SOP und unter Bezug auf einen Validierungsplan... they had on their mind something like 'bezüglich eines Validierungsplans' when a genetive is used.

Ulla Haufe
Local time: 21:20
PRO pts in pair: 156

Peer comments on this answer (and responses from the answerer)
agree  Elisabeth Ghysels
5 mins

agree  Klaus Herrmann: Very likely. I don't see any other way how this could make sense.
11 mins

disagree  gangels: The "eines" is semantically correct. Eg: "in Bezug of ein Dorf oder "eines* anderen Wohnorts".What's wrong with that???
22 hrs
  -> weil es nun mal akkusativisch ist und 'in Bezug auf einen anderen Wohnort' heißt. Du hast ja auch ganz richtig nicht 'eines Dorfes' geschrieben.
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24 mins   confidence: Answerer confidence 4/5Answerer confidence 4/5 peer agreement (net): +1
IF


Explanation:
the sentence is correct, then

The 'Validation Master Plan' specifies:
1) the validation of the individual subunits of the facility (Anlage) AND of a qualifying and validation plan

2) the supply systems ...
under reference to a V-SOP

3)the acceptance criteria

and defines the scope/size of the validation batches to be prepared.

As
I see it, there is no other possibility within the Greman grammar; however, a mistake seems more likely, where *eines* should be replaced by *auf einen*.
Greetings,

Nikolaus


Elisabeth Ghysels
Local time: 21:20
PRO pts in pair: 971

Peer comments on this answer (and responses from the answerer)
agree  Endre Both
10 hrs
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44 mins   confidence: Answerer confidence 4/5Answerer confidence 4/5
sentence


Explanation:
For projects of great complexity, a validation master plan will be implemented for the purpose of specifying the validation of a facility's individual subsets and/or of the maintenance systems (steam, pneumatic air, water, climate) in reference to an applicable V-SOP and/or*of a* plan for qualification or validation including applicable criteria of assumption, in addition to defining the scope [extent?] of the validation charges [responsibilities?] to be established.

gangels
Local time: 13:20
Native speaker of: Native in EnglishEnglish, Native in GermanGerman
PRO pts in pair: 5465
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3 hrs   confidence: Answerer confidence 4/5Answerer confidence 4/5
more grist for the mill


Explanation:
the VMP specifies:
a) the validation of the individual subsystems (or subunits if you will) of the facility or of its supply systems, b) the acceptance criteria
c) the scope or extent of the validation batches/lots

- and it does this by/while making reference to a V-SOP or a qualification or validation plan

(in other the words, the latter item(s) are formally & physically separate from the VMP but are identified as reference documents in the VMP and thus logically form part of the VMP (if you follow me).

As far as the 'eines', I agree with the first two answers; it's sloppy writing or sloppy editing.


Ken Cox
Local time: 21:20
Native speaker of: Native in EnglishEnglish
PRO pts in pair: 5905
Grading comment

Thanks to you all for helping me sort this one out!
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