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Buenas Prácticas de Manufactura

English translation: good [or sound] manufacturing practices

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21:18 Dec 18, 2001
Spanish to English translations [PRO]
Bus/Financial
Spanish term or phrase: Buenas Prácticas de Manufactura
Que corresponde especificar los alcances de los requisitos relativos a los temas de calidad y adecuar su vocabulario a las definiciones adoptadas por el Ente Normalizador Argentino - IRAM - INSTITUTO ARGENTINO DE NORMALIZACION, en lo que respecta a productos. Para el caso específico de los alimentos, lo anterior también es aplicable a los Sistemas de Aseguramiento de la Calidad tales como el Análisis de Riesgos y Control en los Puntos Críticos (HACCP), o las Buenas Prácticas de Manufactura (BPM).
Que la DIRECCION GENERAL DE ASUNTOS JURIDICOS de este Ministerio ha tomado la debida intervención, opinando que la medida propuesta resulta legalmente viable.
sibila
English translation:good [or sound] manufacturing practices
Explanation:
Step-wise Approach to Application of Regulatory Requirements


"Prior to Phase I: need product safety testing and basic characterization info
Pre-clinical
QA & QC, Clinical Monitoring Program
Phase I
Phase II
Good Manufacturing Practices
Full GMP - 21 CFR 210.211"

www.fda.gov/cber/summaries/061100ss.htm

Saludos, Sery




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Note added at 2001-12-18 21:29:26 (GMT)
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Ver la misma referencia para "sound methods and practices".
Selected response from:

Sery
Local time: 01:40
Grading comment
4 KudoZ points were awarded for this answer

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Summary of answers provided
4 +7good [or sound] manufacturing practicesSery
5 +4Good Manufacturing Practices
GoodWords
5GMP
Nikki Graham


  

Answers


6 mins   confidence: Answerer confidence 4/5Answerer confidence 4/5 peer agreement (net): +7
good [or sound] manufacturing practices


Explanation:
Step-wise Approach to Application of Regulatory Requirements


"Prior to Phase I: need product safety testing and basic characterization info
Pre-clinical
QA & QC, Clinical Monitoring Program
Phase I
Phase II
Good Manufacturing Practices
Full GMP - 21 CFR 210.211"

www.fda.gov/cber/summaries/061100ss.htm

Saludos, Sery




--------------------------------------------------
Note added at 2001-12-18 21:29:26 (GMT)
--------------------------------------------------

Ver la misma referencia para "sound methods and practices".

Sery
Local time: 01:40
Native speaker of: Native in SpanishSpanish
PRO pts in pair: 1136

Peer comments on this answer (and responses from the answerer)
agree  Monica Colangelo: Good en este caso
16 mins
  -> Tks

agree  Parrot: También existe "good professional practices" EN CONVENIO INTERNACIONAL.
48 mins
  -> Gracias, pero no creo que es lo mismo.

agree  Thierry LOTTE: agree with Cecilia
1 hr
  -> Gracias, no es lo mismo.

agree  Robert INGLEDEW
1 hr
  -> Gracias

agree  Andrea Bullrich
1 hr
  -> Gracias

agree  Nikki Graham: good
2 hrs
  -> Gracias

agree  kairosz (Mary Guerrero)
5 hrs
  -> Gracias
Login to enter a peer comment (or grade)

7 mins   confidence: Answerer confidence 5/5 peer agreement (net): +4
Good Manufacturing Practices


Explanation:
Resulta que la traducción textual es la correcta. Ver referencias.


    Reference: http://www.cgmp.com/htmfiles/intergmp.htm
    Reference: http://www.fda.gov/cdrh/dsma/cgmphome.html
GoodWords
Mexico
Local time: 00:40
Native speaker of: Native in EnglishEnglish
PRO pts in pair: 1449

Peer comments on this answer (and responses from the answerer)
agree  Ruby Valdez: Totalmente de acuerdo
9 mins

agree  dany2303: Es así!
13 mins

agree  Nikki Graham
2 hrs

agree  Gillian Hargreaves: Also "Good Manufacturing Practice" in the singular
12 hrs
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3 hrs   confidence: Answerer confidence 5/5
GMP


Explanation:
Para apoyar a ambas respuestas, dado que tienes un acrónimo en castellano también. Mira las referencias.


    Reference: http://www.google.com/search?hl=es&q=%22good+manufacturing+p...
Nikki Graham
United Kingdom
Local time: 06:40
Native speaker of: Native in EnglishEnglish
PRO pts in pair: 5584
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