Normas

NOM-073-SSA1-2015

Información principal

Clave de la Norma: NOM-073-SSA1-2015

Título de la Norma: Estabilidad de fármacos y medicamentos (modifica a la NOM-073-SSA1-1993, Estabilidad de medicamentos, publicada el 3 de agosto de 1996).

Estado de la Norma: Vigente

Fecha de publicación en el DOF: 7/6/2016

Fecha de entrada en vigor: 4/12/2016

Información general

Producto, servicio, proceso o sistema: Fármacos y medicamentos

Dependencia(s):

• Secretaría de Salud

Comité que desarrolló la Norma:

• Comité Consultivo Nacional de Normalización de Regulación y Fomento Sanitario

Concordancia internacional

Esta Norma es parcialmente equivalente a los estándares internacionales:

European Medicines Agency, Committee for medicinal products for human use & Committee for medicinal products for veterinary use. Guideline on quality of herbal medicinal products/traditional herbal medicinal products, 2006.

International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use ICH Harmonised Tripartite Guideline Q1A (R2): Stability Testing of New Drug Substances and Products

Food and Drug Administration, Center for Drug Evaluation and Research Guidance for Industry: Stability Testing of Drug Substances and Drug Products

International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use ICH Harmonised Tripartite Guideline Q1C: Stability Testing for New Dosage Forms

International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use ICH Harmonised Tripartite Guideline Q1D: Bracketing and Matrixing Designs for Stability Testing of Drug Substances and Drug Products

International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use ICH Harmonised Tripartite Guideline 5C: Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products.

Grado: Parcialmente equivalente

Historial Documental de la Norma

• Proyecto de Norma Oficial Mexicana PROY-NOM-073-SSA1-2014, Estabilidad de fármacos y medicamentos, así como de remedios herbolarios

  Enlace

• RESPUESTA a los comentarios recibidos respecto del Proyecto de Norma Oficial Mexicana PROY-NOM-073-SSA1-2014, Estabilidad de fármacos y medicamentos, así como de remedios herbolarios, publicado el 26 de febrero de 2015.

  Enlace

• NORMA Oficial Mexicana NOM-073-SSA1-2015, Estabilidad de fármacos y medicamentos, así como de remedios herbolarios.

  Enlace

Referencias Normativas

• NORMA Oficial Mexicana NOM-008-SCFI-2002, Sistema General de Unidades de Medida.

  Enlace

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

  Enlace

• NORMA Oficial Mexicana NOM-072-SSA1-2012, Etiquetado de medicamentos y de remedios herbolarios.

  Enlace

• NORMA Oficial Mexicana NOM-164-SSA1-2013, Buenas prácticas de fabricación para fármacos.

  Enlace

• NORMA Oficial Mexicana NOM-248-SSA1-2011, Buenas prácticas de fabricación para establecimientos dedicados a la fabricación de remedios herbolarios.

  Enlace

• Farmacopea de los Estados Unidos Mexicanos, edición vigente y sus Suplementos.

• International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use ICH Harmonised Tripartite Guideline Q1B. Stability Testing: Photo stability Testing of New Drug Substances and Products

  Enlace

• International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, ICH Harmonised Tripartite Guideline Q1D: Bracketing and Matrixing Designs for Stability Testing of Drug Substances and Drug Products

.

• International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, ICH Harmonised Tripartite Guideline Q5C Stability testing of biotechnological /biological products

  Enlace

• International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, ICH Harmonised Tripartite Guideline Q1E: Evaluation for Stability Data.

  Enlace

• WHO. Guidelines on stability evaluation of vaccines

• WHO. Technical Report Series, No. 992. Annex 4. General guidance on hold-time studies, 2015.

Bibliografía

• Ley General de Salud.

  Enlace

• Ley Federal sobre Metrología y Normalización.

  Enlace

• Reglamento de Insumos para la Salud.

  Enlace

• Reglamento de la Ley Federal sobre Metrología y Normalización.

  Enlace

• Reglamento de la Comisión Federal para la Protección contra Riesgos Sanitarios.

  Enlace

• Food and Drug Administration, Center for Drug Evaluation and Research. Guidance for Industry: Stability Testing of Drug Substances and Drug Products

• European Medicines Agency, Committee for medicinal products for human use & Committee for medicinal products for veterinary use. Guideline on quality of herbal medicinal products/traditional herbal medicinal products

• International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, ICH Harmonised Tripartite Guideline Q1A (R2): Stability Testing of New Drug Substances and Products

• International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, ICH Harmonised Tripartite Guideline Q1C: Stability Testing for New Dosage Forms

• Health Canada. Guidance for Industry: Stability Testing of Existing Drug Substances and Products, 2003.

• Health Canada. Guidance for Industry: Identification, Qualification, and Control of related impurities in Existing Drugs

• International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, ICH Harmonised Tripartite Guideline 5C: Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products.

• Scale-up and Post-Approval Changes (SUPAC) Guidance, Immediate Release Solid Oral Dosage Forms: Chemistry, Manufacturing and Controls, In Vitro 1 Dissolution Testing, and In Vivo Bioequivalence Documentation.

• Drug Stability: Principles and Practices, Carstensen and Rhodes, Third Edition, USA 2000.

• International Pharmaceutical Product Registration: Stability Data, Cartwright & Matthews, USA 1995.

• International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, ICH Harmonised Tripartite Guideline Q3A(R): Impurities in New Drug Substances

• International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, ICH Harmonised Tripartite Guideline Q3B(R): Impurities in New Drug Products

• International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, ICH Harmonised Tripartite Guideline Q3C: Impurities Residual Solvents

• Food and Drug Administration, Center for Drug Evaluation and Research. Guidance for Industry.

• ANDAs: Impurities in Drug Products (Dec. 1998).

• ANDAs: Impurities in Drug Substances (Nov. 1999).

• Chemical Stability of Pharmaceuticals: A Handbook for Pharmacists, 2nd Edition, Connors K. A., Amidon G. L. and Stella V. J., J. Wiley and Sons, USA (1986).

• World Health Organization. Guidelines on stability evaluation of vaccines Annex_3_WHO_TRS_962-3.

• World Health Organization. Technical Report Series, No. 953, 2009. Annex 2, Guidelines for stability testing of active pharmaceutical ingredients and finished pharmaceutical products.

• WHO Technical Report Series, No. 953, 2009. Annex 2, Guidelines for stability testing of active pharmaceutical ingredientes and finished pharmaceutical products, que se ha incluido en la bibliografía de la norma. La misma OMS emitió una tabla de las condiciones de temperatura y humedad por país (table 2, stability conditions for WHO Member States by Region)

Histórico de cancelaciones

NOM-073-SSA1-2005

Revisión Sistemática

• 22 de marzo de 2021
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