Numeral 18 — NOM-059-SSA1-2015, Buenas prácticas de fabricación de medicamentos.

18 Bibliografía

18.1 Ley General de Salud.

18.2 Ley Federal sobre Metrología y Normalización.

18.3 Ley General del Equilibrio Ecológico y la Protección al Ambiente.

18.4 Reglamento de Insumos para la Salud.

18.5 Reglamento de la Ley Federal sobre Metrología y Normalización.

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

18.7 Farmacopea de los Estados Unidos Mexicanos, 11a. Ed. México (2014).

18.8 Suplemento para establecimientos dedicados a la venta y suministro de medicamentos y demás

insumos para la salud, 5ª. Ed. (2014).

18.9 Suplemento de la Farmacopea de los Estados Unidos Mexicanos, México (2015).

18.10 Farmacopea Homeopática de los Estados Unidos Mexicanos, 3a. Ed. México (2015).

18.11 ISO 9000:2005 Quality management systems-Fundamentals and vocabulary.

18.12 ISO 9001:2008 Quality management systems-Requirements.

18.13 ISO 9004:2009 Managing for the sustained success of an organization - A quality management

approach.

18.14 ISO 14644-1:1999. Cleanrooms and associated controlled envi ronments - Part 1: Classification of

air cleanliness.

18.15 ISO 14644-2:2000. Cleanrooms and associated controlled environments - Part 2: Specifications for

testing and monitoring to prove continued compliance with ISO 14644-1.

18.16 ISO 14644-3:2005. Cleanrooms and associated controlled environments - Part 3: Test methods.

18.17 ISO 14644 -4:2001. Cleanrooms and associated controlled environments - Part 4: Design,

construction and start-up.

18.18 ISO 14644-5:2004. Cleanrooms and associated controlled environments - Part 5: Operations.

18.19 ISO 31000:2009. Risk management - Principles and Guidelines on Implementation.

18.20 I ISO/IEC 31010:2009, Risk management - Risk assessment techniques.

18.21 ISO Guide 73:2009. Risk management -- Vocabulary.

18.22 Organización Mundial de la Salud. Manual de bioseguridad en el laboratorio, tercera edición. OMS,

Ginebra, 2005.

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

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

18.24 Parenteral Drug Association. Validation of Moist Heat Sterilization Processes: Cycle Design,

Development, Qualification and Ongoing Control. Technical Report No. 1 (revisad 2007), Suplement Vol. 61,

No. S-1. 2007.

18.25 U.S. Department of Health and Human Services, CDC. Biosafety in Microbiological and Biomedical

Laboratories, 5th. Edition. 2009.

18.26 ISPE. GAMP 5, A Risk-Based Approach to Compliant GxP Computerized Systems. 2008.

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

Analítico. CNQFBM, 2002.

18.28 Health Canada. Laboratory Biosafety Guidelines; 3th. Edition. Canada, 2004.

18.29 James Agalloco, Frederick J. Carleton. Validation of Pharmaceutical Process; 3th edition. Informa

Healthcare, 2008.

18.30 Pharmaceutical Production. An engineering guide, Edited by Bill Bennett and Graham Cole;

Institution of Chemical Engineers (IChemE), 2003.

18.31 Gary Walsh. Pharmaceutical Biotechnology. Concepts and Applications. Ed. John Wiley and Sons

Ltd. 2007.

18.32 Anexo 20 “Buenas Prácticas de Fabricación de Medicamentos” PIC, Marzo 2014.

18.33 Guía de “Prácticas de Correcta Fabricación”, Ministerio de Salud de España “Gestión de Riesgo”

2008.

18.34 FDA (2004) Pharmaceutical CGMPS for the 21st century - A risk-based approach. Final report.

18.35 ICH (2005) “Quality risk management ICH Harmonised Tripartite Guideline Guideline Q9.

18.36 ICH (2008) Pharmaceutical quality system. ICH Harmonised Tripartite Guideline Q10.

18.37 ICH (2009) Pharmaceutical development. ICH Harmonised Tripartite Guideline Q8 (R2).

18.38 ICH (2011). Development and Manufacture of Drug Substances (Chemic al Entities and

Biotechnological/Biological Entities). Draft Consensus Guideline Q11.

18.39 Vesper, J. L. (2006) Risk assessment and risk m anagement in the pharmaceutical industry. Clear

and simple. PDA/DHI.

18.40 CEI/IEC (1985) Techniques d’analyse de la fiabilité des systèmes. Procédured’analyse des modes

de défaillance et de leurseffets (AMDE) / Analysis techniques for system reliability. Procedure for failure mode

and effects analysis (FMEA). Norme international/International standard 608121985.

18.41 WHO (2003) Hazard and risk analysis in pharmaceutical products. Technical Report Series, No. 908.

Annex 7.