anglais: batch recordrusse translation: производственная ведомость для партии  KudoZ The KudoZ network provides a framework for translators ... More  |
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| ENTRÉE DU GLOSSAIRE (VENANT DE LA QUESTION CI-DESSOUS) | | Terme ou expression en anglais : | batch record | | Traduction en russe : | производственная ведомость для партии | | Entrée par : | Elene P. |
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traduction anglais vers russe [PRO]
Fabrication | | Terme ou expression en anglais : batch record | Nel corso di ispezione sono stati visionati alcuni batch record ...
речь идет о производстве.. |
| | | производственная ведомость для партии | Explication :
Это документация, где описан производственный процесс: вид сырья, оборудование, данные анализов готовой продукции на качество.
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Note added at 12 mins (2008-03-03 09:22:37 GMT)
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Из моего архива (выписки из глоссариев на английском, все из области производства фармпрепаратов):
Batch record: Documents the production of a drug substance or drug product under GMP including raw materials and equipment used in production. The CMO will carry out a series of QC tests on the finished product before their QC department releases it. These documents (called Batch Records) are used in the CMC submission for approval of the finished drug product.
A batch record is typically a packet of information containing the master formula and processing steps that accompany a batch of product through the manufacturing process. These records are typically retained for seven years and typically reviewed in audits by the FDA. |
| Réponse sélectionnée de :
 Marina Aleyeva
Ukraine
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4 points KudoZ ont été attribués à cette réponse |
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6 minutes confiance :   approbation des pairs (net) : +1 |
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The translation workplace 
