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  3. Medical: Pharmaceuticals

Änderungsqualifizierung

English translation: Requalification after change

GLOSSARY ENTRY (DERIVED FROM QUESTION BELOW)
German term or phrase:Änderungsqualifizierung
English translation:Requalification after change
Entered by: Sanni Kruger (X)

08:56 Aug 24, 2017
German to English translations [PRO]
Medical - Medical: Pharmaceuticals / Validation report
German term or phrase: Änderungsqualifizierung
I’ve just started working on the Validation report for the process validation of a manufacturing process;
On the title page I have under the heading “Grund” (reason):
Initial-/Erstqualifizierung:
Änderungsqualifizierung:
Requalifizierung:
Each with a box to be ticked.
I simply can’t get my head around “Änderungsqualifizierung”. It does not occur anywhere else in the docyment. Any thoughts?
Sanni Kruger (X)
United Kingdom
Local time: 05:11
Requalification after change
Explanation:
Does this help: http://www.planttech.de/meta/glossar/aenderungsqualifizierun... ? "Eine Änderungsqualifizierung ist eine Qualifizierungsmaßnahme, die im Anschluss an Änderungsarbeiten bei einer qualifizierten Anlage durchgeführt wird."

I'm not sure if there is a snappy English word for it. This one http://www.pharmaguideline.com/2010/12/qualification-of-syst... uses the phrase "Systems and equipment should undergo periodic requalification, as well as requalification after change". Maybe other answers will be forthcoming.
Selected response from:

Mair A-W (PhD)
Germany
Local time: 06:11
Grading comment
Many thanks, this was exactly what I was looking for.
4 KudoZ points were awarded for this answer



Summary of answers provided
3 +3Requalification after change
Mair A-W (PhD)


  

Answers


20 mins   confidence: Answerer confidence 3/5Answerer confidence 3/5 peer agreement (net): +3
Requalification after change


Explanation:
Does this help: http://www.planttech.de/meta/glossar/aenderungsqualifizierun... ? "Eine Änderungsqualifizierung ist eine Qualifizierungsmaßnahme, die im Anschluss an Änderungsarbeiten bei einer qualifizierten Anlage durchgeführt wird."

I'm not sure if there is a snappy English word for it. This one http://www.pharmaguideline.com/2010/12/qualification-of-syst... uses the phrase "Systems and equipment should undergo periodic requalification, as well as requalification after change". Maybe other answers will be forthcoming.

Mair A-W (PhD)
Germany
Local time: 06:11
Native speaker of: English
PRO pts in category: 8
Grading comment
Many thanks, this was exactly what I was looking for.

Peer comments on this answer (and responses from the answerer)
agree  Johanna Timm, PhD: http://tinyurl.com/y6whkykf
8 hrs
agree  David Hollywood
9 hrs
agree  Ramey Rieger (X)
20 hrs
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