This question was closed without grading. Reason: Answer found elsewhere
Jun 1, 2010 13:05
14 yrs ago
14 viewers *
French term
échantillon de contre-expertise
French to English
Tech/Engineering
Medical: Pharmaceuticals
Drug manufacturing
I am translating an audit that looks at every step of the manufacture of a given drug (in France), from the delivery of raw materials to filling, packaging, raw materials/finished product reconciliation, and stability testing. One section is entitled “Inventaire des échantillons de contre-expertise et résultat de l’inspection annuelle de ces échantillons”. This very brief section contains lists of lot numbers, production dates and room numbers, and a sentence indicating that these samples are visually inspected. The previous section concerns microbiological testing, the following section, stability testing. Any ideas as to what “échantillon de contre-expertise” might be in English? Thanks.
Proposed translations
(English)
Proposed translations
8 mins
counter-valuation sample
counter-valuation sample
+1
12 mins
backup sample
Can't find the appropriate bilingual pharma manufacturing reference yet, but in the sports world, the "échantillon de contre-expertise" is the "B" sample or back-up sample that is tested when an athletes first sample (the A sample) comes up positive for performance enhancing drugs...
Example sentence:
take the specified quantity of sample to enable all processing and testing to occur and backup samples to be stored
Note from asker:
When I first came across this term in this text, my gut instinct was "backup samples". I'm inclined to think that Joanne's suggestion is correct, since the author of the text in question uses another term of retention samples and since the échantillons de contre-expertise are stored in different rooms. |
Peer comment(s):
agree |
philgoddard
: Yes, I think contre-expertise implies another test/inspection carried out by someone else.
15 mins
|
Thanks. I found "second assessment" as a translation of "contre-expertise" in my Collins-Robert
|
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agree |
Isabelle17
4 hrs
|
Merci bien!
|
|
agree |
Drmanu49
4 hrs
|
Merci
|
|
disagree |
liz askew
: backup = spare, reserve, substitute
6 hrs
|
OK. I'm using the common lab term, which is "backup sample"
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disagree |
Lionel_M (X)
: d'accord avec Liz; "backup sample" c'est l'échantillon de réserve
1 day 8 hrs
|
2 hrs
(expert) confirmation sample (to validate or not the first expert sample analysis)
Hello,
Just a wild guess...
échantillon = sample
contre-expertise = second opinion = expert confirmation to validate the first expert analysis sample (here)???
If the results of this confirmation sample validate the first sample, .... Send the samples to a Massachusetts or EPA certified laboratory to be analyzed ...
www.mass.gov/dep/water/laws/8704.doc
I hope this helps.
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Note added at 2 hrs (2010-06-01 15:21:23 GMT)
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ON, Canada; Web http://www.denina... Bio DSCS Scientific Consulting offers expert sample analysis, method development and writing services. ...
twitter.com/DeninaSimmons/favorites
Just a wild guess...
échantillon = sample
contre-expertise = second opinion = expert confirmation to validate the first expert analysis sample (here)???
If the results of this confirmation sample validate the first sample, .... Send the samples to a Massachusetts or EPA certified laboratory to be analyzed ...
www.mass.gov/dep/water/laws/8704.doc
I hope this helps.
--------------------------------------------------
Note added at 2 hrs (2010-06-01 15:21:23 GMT)
--------------------------------------------------
ON, Canada; Web http://www.denina... Bio DSCS Scientific Consulting offers expert sample analysis, method development and writing services. ...
twitter.com/DeninaSimmons/favorites
3 hrs
reserve/retention samples
-
--------------------------------------------------
Note added at 3 hrs (2010-06-01 16:42:28 GMT)
--------------------------------------------------
Impurity Profile of Active Pharmaceutical Ingredient : A Review ... during the manufacturing process and/or storage of the drug substance. .... Retention samples (reserve sample) - Retain reserve portions of all sample ...
www.pharmainfo.net/.../impurity-profile-active-pharmaceutic... - Cached - Similar
Amazon.com: Good Manufacturing Practices for Pharmaceuticals: A ... Good Manufacturing Practices for Pharmaceuticals, Sixth Edition (Drugs and the ... authorizing civil money penalties, reserve sample retention, ...
www.amazon.com › ... › Medicine › Pharmacology › Pharmacy - Cached - Similar
[PDF] Current Good Manufacturing Practices Checklist For Pharmaceutical ... File Format: PDF/Adobe Acrobat - Quick View
methods and controls used for the manufacturing, processing, ... records be readily available for inspection during the retention period at the .... For active ingredient in a drug product the reserve sample must be retained for 1 year ...
www.troutmansanders.com/.../Current Good Manufacturing Prac... - Similar
[PDF] Q 7 Good Manufacturing Practice for Active Pharmaceutical Ingredients File Format: PDF/Adobe Acrobat - Quick View
marketing/manufacturing authorizations or drug applications. ...... 11.7 Reserve/Retention Samples. 11.70 The packaging and holding of reserve samples is ...
www.ema.europa.eu/pdfs/human/ich/410600en.pdf
[DOC] RESERVE SAMPLES (DES) File Format: Microsoft Word - View as HTML
The reserve samples for drug products shall be stored in the same immediate container, ... excipients are stored for manufacturing or in one that is equivalent. ... Type of Reserve Sample, Retention time. Drug substance or Excipients ...
www.innovatgxp.com/Resource/SOP/assets/Reserve Samples.doc
Justia :: 21 C.F.R. § 211.170 Reserve samples. 21 C.F.R. § 211.170 Reserve samples. Title 21 - Food and Drugs. Title 21: Food and Drugs PART 211—CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED ... The retention time is as follows: (1) For an active ingredient in a drug product ...
law.justia.com/us/cfr/title21/21-4.0.1.1.10.9.1.5.html - Cached - Similar
1 2 3 4 5 6 7 8 9 10 Next
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--------------------------------------------------
Note added at 3 hrs (2010-06-01 16:42:28 GMT)
--------------------------------------------------
Impurity Profile of Active Pharmaceutical Ingredient : A Review ... during the manufacturing process and/or storage of the drug substance. .... Retention samples (reserve sample) - Retain reserve portions of all sample ...
www.pharmainfo.net/.../impurity-profile-active-pharmaceutic... - Cached - Similar
Amazon.com: Good Manufacturing Practices for Pharmaceuticals: A ... Good Manufacturing Practices for Pharmaceuticals, Sixth Edition (Drugs and the ... authorizing civil money penalties, reserve sample retention, ...
www.amazon.com › ... › Medicine › Pharmacology › Pharmacy - Cached - Similar
[PDF] Current Good Manufacturing Practices Checklist For Pharmaceutical ... File Format: PDF/Adobe Acrobat - Quick View
methods and controls used for the manufacturing, processing, ... records be readily available for inspection during the retention period at the .... For active ingredient in a drug product the reserve sample must be retained for 1 year ...
www.troutmansanders.com/.../Current Good Manufacturing Prac... - Similar
[PDF] Q 7 Good Manufacturing Practice for Active Pharmaceutical Ingredients File Format: PDF/Adobe Acrobat - Quick View
marketing/manufacturing authorizations or drug applications. ...... 11.7 Reserve/Retention Samples. 11.70 The packaging and holding of reserve samples is ...
www.ema.europa.eu/pdfs/human/ich/410600en.pdf
[DOC] RESERVE SAMPLES (DES) File Format: Microsoft Word - View as HTML
The reserve samples for drug products shall be stored in the same immediate container, ... excipients are stored for manufacturing or in one that is equivalent. ... Type of Reserve Sample, Retention time. Drug substance or Excipients ...
www.innovatgxp.com/Resource/SOP/assets/Reserve Samples.doc
Justia :: 21 C.F.R. § 211.170 Reserve samples. 21 C.F.R. § 211.170 Reserve samples. Title 21 - Food and Drugs. Title 21: Food and Drugs PART 211—CURRENT GOOD MANUFACTURING PRACTICE FOR FINISHED ... The retention time is as follows: (1) For an active ingredient in a drug product ...
law.justia.com/us/cfr/title21/21-4.0.1.1.10.9.1.5.html - Cached - Similar
1 2 3 4 5 6 7 8 9 10 Next
Search within results - Language Tools - Search Help - Dissatisfied? Help us improve - Try Google Experimental
Google Home - Advertising Programs - Business Solutions - Privacy - About Google
+1
30 mins
samples for second opinion/samples requiring a second opinion
http://docs.google.com/viewer?a=v&q=cache:IDAFweMAIr0J:argen...
see page 5
http://webcache.googleusercontent.com/search?q=cache:TEOQj0I...
here = second opinion
contre - Dictionnaire Français-Anglais WordReference.com
- [ Translate this page ]
contre-expertise, nf, (en assurance), resurvey. contre-expertise, nf, (seconde expertise), second opinion. contre-feu, nm, (feu de prévention), backfire ...
www.wordreference.com/fren/contre - Cached - Similar
Show more results from www.wordreference.com
[PDF]
Simple, rapid basic tests for evaluation of quality of oseltamivir
File Format: PDF/Adobe Acrobat - View as HTML
Visual and physical inspection of pharmaceutical products is the first step in ... For a second opinion, refer additional samples to a fully-fledged drug ...
www.usp.org/pdf/EN/dqi/oseltamivirTests.pdf - Similar
NCCN Drug and Biologics Compendium - Panel Members
And in more than a third of the samples, a second opinion resulted in a major .... The drug, still in clinical trials, may be approved by the Food and Drug ...
www.nccn.org/about/publications/publicationsinfo.asp?...6 - Cached - Similar
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Note added at 37 mins (2010-06-01 13:43:17 GMT)
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and page 7 here
http://docs.google.com/viewer?a=v&q=cache:nz9PHpj_FtAJ:www.g...
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Note added at 6 hrs (2010-06-01 19:11:00 GMT)
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http://webcache.googleusercontent.com/search?q=cache:_POXc_k...
8. L’article 7 de ladite directive se lit comme suit:
8. Article 7 of the directive is worded as follows:
«1. Des échantillons des produits visés à l’article 6 paragraphe 1 points b ) à f ) peuvent être prélevés aux fins d’analyse.
1. Samples of the products enumerated in Article 6(1)(b) to (f) may be taken for the purposes of analysis.
Les États membres prennent les dispositions nécessaires afin d’assurer aux assujettis le bénéfice d’une éventuelle contre-expertise.
Member States shall take the necessary steps to ensure that those subject to inspection may apply for a second opinion.
2. Les analyses sont effectuées par des laboratoires officiels.
2. The analyses shall be carried out by official laboratories.
Les États membres peuvent également habiliter d’autres laboratoires à effectuer ces analyses.»
Member States may also empower other laboratories to carry out these analyses.’
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Note added at 6 hrs (2010-06-01 19:27:33 GMT)
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http://dictionary.reverso.net/french-english/expertise
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Note added at 6 hrs (2010-06-01 19:50:40 GMT)
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This site tells you exactly what is involved re "contre-expertise":
http://books.google.co.uk/books?id=ajSSOufin5wC&pg=RA2-PA315...
see page 5
http://webcache.googleusercontent.com/search?q=cache:TEOQj0I...
here = second opinion
contre - Dictionnaire Français-Anglais WordReference.com
- [ Translate this page ]
contre-expertise, nf, (en assurance), resurvey. contre-expertise, nf, (seconde expertise), second opinion. contre-feu, nm, (feu de prévention), backfire ...
www.wordreference.com/fren/contre - Cached - Similar
Show more results from www.wordreference.com
[PDF]
Simple, rapid basic tests for evaluation of quality of oseltamivir
File Format: PDF/Adobe Acrobat - View as HTML
Visual and physical inspection of pharmaceutical products is the first step in ... For a second opinion, refer additional samples to a fully-fledged drug ...
www.usp.org/pdf/EN/dqi/oseltamivirTests.pdf - Similar
NCCN Drug and Biologics Compendium - Panel Members
And in more than a third of the samples, a second opinion resulted in a major .... The drug, still in clinical trials, may be approved by the Food and Drug ...
www.nccn.org/about/publications/publicationsinfo.asp?...6 - Cached - Similar
--------------------------------------------------
Note added at 37 mins (2010-06-01 13:43:17 GMT)
--------------------------------------------------
and page 7 here
http://docs.google.com/viewer?a=v&q=cache:nz9PHpj_FtAJ:www.g...
--------------------------------------------------
Note added at 6 hrs (2010-06-01 19:11:00 GMT)
--------------------------------------------------
http://webcache.googleusercontent.com/search?q=cache:_POXc_k...
8. L’article 7 de ladite directive se lit comme suit:
8. Article 7 of the directive is worded as follows:
«1. Des échantillons des produits visés à l’article 6 paragraphe 1 points b ) à f ) peuvent être prélevés aux fins d’analyse.
1. Samples of the products enumerated in Article 6(1)(b) to (f) may be taken for the purposes of analysis.
Les États membres prennent les dispositions nécessaires afin d’assurer aux assujettis le bénéfice d’une éventuelle contre-expertise.
Member States shall take the necessary steps to ensure that those subject to inspection may apply for a second opinion.
2. Les analyses sont effectuées par des laboratoires officiels.
2. The analyses shall be carried out by official laboratories.
Les États membres peuvent également habiliter d’autres laboratoires à effectuer ces analyses.»
Member States may also empower other laboratories to carry out these analyses.’
--------------------------------------------------
Note added at 6 hrs (2010-06-01 19:27:33 GMT)
--------------------------------------------------
http://dictionary.reverso.net/french-english/expertise
--------------------------------------------------
Note added at 6 hrs (2010-06-01 19:50:40 GMT)
--------------------------------------------------
This site tells you exactly what is involved re "contre-expertise":
http://books.google.co.uk/books?id=ajSSOufin5wC&pg=RA2-PA315...
Peer comment(s):
agree |
Lionel_M (X)
1 day 8 hrs
|
Thank you!
|
Discussion