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NOM-059-SSA1-2013, Good manufacturing practices of drug products. Published in the DOF, July 22, 2013

This Standard is under the oversight of the SSA = (Secretaría de Salud - Secretary of Health) Environmental Health

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

A new Standard "NOM-059-SSA1-2015, Good Manufacturing Practices of Drug Products." was published in the DOF Feb. 5, 2016 and takes effect August 04, 2015. We are preparing a translation of the new standard, if you wish to be notified when the new standard is translated please contact us.




NORMA Oficial Mexicana NOM-059-SSA1-2013, Buenas prácticas de fabricación de medicamentos.

Official Mexican Standard NOM-059-SSA1-2013, Good manufacturing practices of drug products. 




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.         Documentación.

5.         Documentation.

6.         Sistema de gestión de calidad.

6.         Quality management system.

7.         Personal.

7.         Personnel.

8.         Instalaciones y equipo.

8.         Installations and equipment.

9.         Validación y calificación.

9.         Validation and qualification.

10.       Sistemas de fabricación.

10.       Manufacturing systems.

11.       Devoluciones.

11.       Returns.

12.       Liberación de producto terminado.

12.       Release of a finished product.

13.       Control de calidad.

13.       Quality control.

14.       Retiro de producto del mercado.

14.       Withdrawal of a product for the market.

15.       Contratistas.

15.       Contractors.

16.       Destino final de residuos.

16.       Final destination of wastes.

17.       Concordancia con normas internacionales y mexicanas.

18.       Concordance with international and Mexican standards.

18.       Bibliografía.

19.       Bibliography.

19.       Observancia.

20.       Observance.

20.       Vigencia.

21.       Effective period.

21.       Apéndice A (Normativo). Áreas de fabricación.

22.       Obligatory Appendix A. Areas of manufacturing.




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