Glossary entry

Italian term or phrase:

dossier di tecnica farmaceutica

English translation:

Chemistry, Manufacturing, and Controls (CMC) technical section

Added to glossary by Peter Waymel
Apr 25, 2013 16:58
11 yrs ago
3 viewers *
Italian term

dossier di tecnica farmaceutica

Italian to English Medical Medical: Pharmaceuticals
Regarding the technical specifications, procedures to produce the drug, information on controls/validations, regarding the manufacture of a drug for veterinary use.

Thanks,

Peter

Proposed translations

+1
2 hrs
Selected

Chemistry, Manufacturing, and Controls (CMC) technical section

I'm not wholly convinced, as the term is not very common in Italian, but I think CMC is equivalent, unless you think a more literal translation would be in order. Depends on the purpose of the text I suppose.
CMC is described as follows at http://www.fda.gov/AnimalVeterinary/ResourcesforYou/AnimalHe...

In the Chemistry, Manufacturing, and Controls (CMC) technical section, the drug sponsor describes the plan for making the drug. This plan includes:

What ingredients will be used to make the drug;
Where the ingredients will come from;
Where the drug will be made;
How it will be made;
How it will be packaged;
How it can be stored (under what conditions); and
How long it can be stored (this is important in determining the drug’s expiration date).

A big portion of the CMC puzzle piece is looking at what tests the drug sponsor will use to make sure the drug is high-quality and safe. Another important part is deciding when FDA’s investigators should inspect the manufacturing facilities where the drug is made. When an inspection is needed, FDA’s investigators work with scientists at CVM to make sure the manufacturing facilities are using the correct equipment and methods to consistently produce a high-quality and safe drug.

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Note added at 13 hrs (2013-04-26 06:14:15 GMT)
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let me try the link again: http://www.fda.gov/AnimalVeterinary/ResourcesforYou/AnimalHe...
Peer comment(s):

agree Peter Cox
6 hrs
neutral philgoddard : Your reference doesn't work, but this appears to be specific to the FDA, so not appropriate here.
7 hrs
I'm not sure whether that makes it inappropriate, as that depends on the purpose of the text, the readership etc. I certainly wonder why the Italian company used that term, whether it is already a (mis)translation etc. 'Tis what makes pharma fun
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4 KudoZ points awarded for this answer. Comment: "Thanks Anthony, this looks pretty exact. "
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