Numeral 18 — NOM-164-SSA1-2015, Buenas prácticas de fabricación de fármacos.

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

18.9 ISO 9001:2008 Quality management systems-Requirements.

18.10 ISO 9004:2009 Managing for the sustained succes s of an organization -A quality management

approach.

18.11 ISO 14644-1:1999. Cleanrooms and associated controlled environments -- Part 1: Classification of

air cleanliness.

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

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

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

18.14 ISO 14644 -4:2001. Cleanrooms and associated controlled envi ronments -- Part 4: Design,

construction and start-up.

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

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

18.17 Colegio Nac ional de Químicos Farmacéuticos Biólogos México. Guía de Validación del Método

Analítico. CNQFBM, 2002.

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

Healthcare, 2008.