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NOM-059-SSA1-1993,  Good manufacturing practices for establishments of the pharmaceutical chemical industry designated for the manufacture of medications.
   
 

This Standard is under the oversight of the SSA = (Secretaría de Salud - Secretary of Health) Environmental Health  www.ssa.gob.mx

LAW, REGULATION, OR NOM - what is the difference?  

This NOM has been cancelled and replaced by

NOM-059-SSA1-2006, Good practices of fabrication for establishments of the chemical pharmaceutical industry dedicated to the fabrication of drug products.  Published in the DOF on Dec. 22, 2008 - effective June 20, 2009

The new translation will be available soon, if you want to be notified  contact glenn@mexicanlaws.net

 

 

 

NOM-059-SSA1-1993,
Buenas prácticas de fabricación para establecimientos de la industria químico farmacéutica dedicados a la fabricación de medicamentos.
NOM-059-SSA1-1993,
Good manufacturing practices for establishments of the pharmaceutical chemical industry designated for the manufacture of medications.
INDICE INDEX

 

 

0. Introducción

0. Introduction

1. Objetivo y campo de aplicación

1. Objective and field of Application

2. Referencias

2. References

3. Definiciones

3. Definitions

4. Símbolos y abreviaturas

4. Symbols and abbreviations

5. Organización de un establecimiento

5. Organization of an establishment

6. Personal

6. Personnel

7. Documentación legal y técnica

7. Legal and Technical Documentation

8. Diseño y construcción de un establecimiento de la industria químico farmacéutica

8. Design and construction of an establishment of the pharmaceutical chemical industry

9. Control de la fabricación

9. Control of manufacturing

10. Equipo de fabricación

10. Equipment of manufacturing

11. Destrucción y disposición final de residuos

11. Destruction and final disposition of wastes

12. Concordancia con normas internacionales y mexicanas

12. Concordance with international and Mexican Standards

13. Bibliografía

13. Bibliography

14. Observancia de la norma

14. Observance to the Standard

15. Anexos

15. Anexos (Supplements)
I. Clasificación de áreas I. Classification of areas

16. Vigencia

16. Oversight

 

 

1. Objetivo y campo de aplicación

1. Objective and Field of Application

Esta Norma Oficial Mexicana establece los requisitos mínimos necesarios para el proceso de los medicamentos y/o productos biológicos comercializados en el país, con el objeto de proporcionar medicamentos de calidad al consumidor.

This Official Mexican Standard establishes the minimum requirements necessary for the process of the medications and/or biological products that are commercialized in the country, for the purpose of providing quality medications to the consumer.

Es de observancia obligatoria en establecimientos de la industria químico-farmacéutica dedicados a la fabricación de medicamentos y productos biológicos para uso humano.

It is of obligatory observance in establishments of the pharmaceutical chemical industry designated for the fabrication of medications and biological products for human use.
 

 

$49.00

 

 

 

 

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