Glossary entry (derived from question below)
Nov 2, 2014 23:45
9 yrs ago
3 viewers *
Spanish term
identidad
Spanish to English
Medical
Medical: Pharmaceuticals
Hello all! I am translating a quality manual for a pharmaceutical company in Mexico. Below is a passage in which the term "identidad" appears in context, which is the objective for the section on manufacturing equipment:
Asegurar que todos los equipos de fabricación que afecten la calidad de los productos estén debidamente calificados en función de su diseño, construcción, operación y tamaño, de tal modo que permita a los operadores realizar sus actividades eficientemente, garantizando con esto la seguridad, *identidad,* potencia y pureza del producto fabricado.
I look forward to your responses. Thanks for your help!
Asegurar que todos los equipos de fabricación que afecten la calidad de los productos estén debidamente calificados en función de su diseño, construcción, operación y tamaño, de tal modo que permita a los operadores realizar sus actividades eficientemente, garantizando con esto la seguridad, *identidad,* potencia y pureza del producto fabricado.
I look forward to your responses. Thanks for your help!
Proposed translations
(English)
Change log
Nov 3, 2014 01:15: Michele Fauble changed "Language pair" from "Spanish to English" to "English to Spanish"
Nov 3, 2014 01:16: Michele Fauble changed "Language pair" from "English to Spanish" to "Spanish to English"
Nov 3, 2014 10:49: Yana Dovgopol changed "Term asked" from "identity" to "identidad"
Proposed translations
+1
8 hrs
Spanish term (edited):
identity
Selected
identity
"Identidad" simply means that the product really is what it's supposed to be and what the label says it is: it's identity.
"1. Identidad: Pruebas que aseguren que el material contenido en el envase se corresponde con lo indicado en la etiqueta del mismo."
http://www.ucv.ve/fileadmin/user_upload/facultad_farmacia/ca...
"The Current Good Manufacturing Practice (CGMP) regulations address component sampling and testing primarily at 21 CFR 211.84. These regulations require representative samples of each shipment of each lot of active and inactive component (or raw materials) to be tested to confirm the identity of the component as labeled prior to release for use in drug product manufacturing. The regulations acknowledge that more than one test may be needed to ascertain a component’s identity. For the purpose of this answer, a component’s identity is its chemical structure and its physical form (e.g., polymorph, solvate, and appearance) including, if appropriate, its stereochemistry or immunochemistry. "
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInforma...
The same list of properties, sometimes with minor variations, is standard in English:
"Therefore, changes in the manufacturing process, equipment or facilities may require additional clinical studies to demonstrate the product's continued safety, identity, purity and potency."
http://www.fda.gov/Drugs/DevelopmentApprovalProcess/ HowDrug...
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Note added at 8 hrs (2014-11-03 08:01:39 GMT)
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Sorry: I meant to put "its identity" in line 1, not "it's identity".
"1. Identidad: Pruebas que aseguren que el material contenido en el envase se corresponde con lo indicado en la etiqueta del mismo."
http://www.ucv.ve/fileadmin/user_upload/facultad_farmacia/ca...
"The Current Good Manufacturing Practice (CGMP) regulations address component sampling and testing primarily at 21 CFR 211.84. These regulations require representative samples of each shipment of each lot of active and inactive component (or raw materials) to be tested to confirm the identity of the component as labeled prior to release for use in drug product manufacturing. The regulations acknowledge that more than one test may be needed to ascertain a component’s identity. For the purpose of this answer, a component’s identity is its chemical structure and its physical form (e.g., polymorph, solvate, and appearance) including, if appropriate, its stereochemistry or immunochemistry. "
http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInforma...
The same list of properties, sometimes with minor variations, is standard in English:
"Therefore, changes in the manufacturing process, equipment or facilities may require additional clinical studies to demonstrate the product's continued safety, identity, purity and potency."
http://www.fda.gov/Drugs/DevelopmentApprovalProcess/ HowDrug...
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Note added at 8 hrs (2014-11-03 08:01:39 GMT)
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Sorry: I meant to put "its identity" in line 1, not "it's identity".
Peer comment(s):
| agree |
M. C. Filgueira
: Sin duda. Una referencia de la European Medicines Agency (EMA): http://www.ema.europa.eu/docs/en_GB/document_library/Scienti... (apartado 4.1.2, página 10). Muchos saludos.
1 day 8 hrs
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Gracias y saludos, María Claudia. Tomo nota de la referencia.
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4 KudoZ points awarded for this answer.
Comment: "Thanks!"
1 hr
TravellingTrans
United States
United States
Native in English
United States
Timely Translation Turnaround
Native in: English (Variant: US)
Works in: Spanish to English, Chinese to English
Spanish term (edited):
identity
reputation or recogniztion
based on the idea I'm taking from the context, it's essentially saying that with the quality of the tools and the work, the security, "reputation", power, and purity of the manufactured product can be guaranteed.
recognition might also work but I like reputation better
recognition might also work but I like reputation better
2 hrs
Raul Yanez
Ecuador
Ecuador
Native in Spanish
Ecuador
Native in: Spanish (Variant: Latin American) 
Works in: English to Spanish, Spanish to English
Spanish term (edited):
identity
identidad
identity
2 hrs
Michael Liu
China
China
China
Chinese, English, Spanish Translation
Native in: Chinese (Variants: Traditional, Mandarin)
Works in: English to Chinese, Spanish to Chinese, Chinese to English, and 3 more.
Spanish term (edited):
identity
Identidad: todos productos se deben mantener la misma especificación en todos aspectos.
The same products should have same specification in all aspects, regardless of its production date, batch, etc.
2 hrs
Spanish term (edited):
identity
igualdad de condiciones
Mantener los productos en igualdad de condiciones referente a la sespecificaiones.
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Note added at 12 hrs (2014-11-03 12:42:56 GMT)
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equality/similarity de conditions
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Note added at 12 hrs (2014-11-03 12:42:56 GMT)
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equality/similarity de conditions
20 hrs
Trademark
cheers
Discussion
Te aconsejería poner el término que preguntas en el idioma original, identidad.