Buenas Prácticas de Manufactura

English translation: good [or sound] manufacturing practices

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: 05:49

Grading comment

4 KudoZ points were awarded for this answer

Summary of answers provided

4 +7

good [or sound] manufacturing practices

Sery

5 +4

Good Manufacturing Practices

Margaret Schroeder

GMP

Nikki Graham

Answers

6 mins confidence:

peer agreement (net): +7

good [or sound] manufacturing practices

Sery
Local time: 05:49
Native speaker of:

Spanish
PRO pts in pair: 1136

7 mins confidence:

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

Margaret Schroeder
Mexico
Local time: 04:49
Native speaker of:

English
PRO pts in pair: 1449

3 hrs confidence:

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: 11:49
Native speaker of: English
PRO pts in pair: 5596

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