Numeral 12 — NOM-257-SSA1-2014, En materia de medicamentos biotecnológicos.

12 Bibliografía

12.1 Ley General de Salud.

12.2 Ley Federal sobre Metrología y Normalización.

12.3 Reglamento de Insumos para la Salud.

12.4 Reglamento de la Ley Federal sobre Metrología y Normalización.

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

12.6 Farmacopea de los Estados Unidos Mexicanos, 10a. ed. México (2009).

12.7 ISO 31000:2009. Principles and Guidelines on Implementation.

12.8 Organización Mundial de la Salud. Manual de bios eguridad en el laboratorio, tercera edición. OMS,

Ginebra, 2005.

12.9 World Health Organization. Quality Assurance of Pharmaceuticals. A compendium of guidelines and

related materials, Vol. 2, 2a. Edition, 2007.

12.10 World Health Organization. Guid elines on evaluation of similar Bi otherapeutic Products (SBPs),

ECBS, October 2009.

12.11 World Health Organization. Proposed WHO Risk Management Plan for dealing with copy biologicals

inappropriately licensed as “Biogenerics”. Draft_11 May 2012.

12.12 World Health Organization. Guidelines on the Qualit y, Safety, and Efficacy of Biotherapeutic Protein

Products prepared by Recombinant DNA Technology. Replacement of Annex 3 of WHO Technical Report

Series, No. 814 2013.

12.13 World Health Organization. Regulatory expecta tions and risk assessment for biotherapeutic

products. Scientific Principles to Consider. 2014.

12.14 Colegio Nacional de Químicos Farmacéuticos Biólogos México. Guía de Validación del Método

Analítico. CNQFBM, 2002.

12.15 Gary Walsh. Pharmaceutical Biotechnology. Co ncepts and Applications. Ed. John Wiley and Sons

Ltd. 2007.