Numeral 17 — NOM-059-SSA1-2015, Buenas prácticas de fabricación de medicamentos.

17 Concordancia con normas internacionales y mexicanas

Esta Norma es parcialmente equivalente a los estándares internacionales:

17.1 EudraLex. Volume 4, Good manufacturing practice (GMP) Guidel ines, Introduction, Part I, Part III and. Annexes 1, 2, 6, 8, 9, 11, 13, 14, 15 and 19.

17.2 Pharmaceutical Inspection Convention/Pharmaceutical Inspection Co -operation Scheme. Explanatory. notes for Pharmaceutical Manufacturers on the Preparation of a Site Master File. January 2011.

17.3 Pharmaceutical Inspection Convention/Pharmaceutical Inspection Co -operation Scheme. Guide to. Good Manufacturing Practice for Medicinal Products Annexes. October 2015.

17.4 Pharmaceutical Inspection Convention/Pharmaceutical Inspection Co -operation Scheme. Guide to. Good Manufacturing Practice for Medicinal Products Part I. October de 2015.

17.5 Pharmaceutical Inspection Convention/Pharmaceutical Inspection Co -operation Scheme. Guide to. Good Manufacturing Practice for Medicinal Products Part II. October de 2015

17.6 Pharmaceutical Inspection Convention/Pharmaceutical Inspection Co -operation Scheme. PIC/S GMP. Guide for Blood Establishments. September 2007.

17.7 Pharmaceutical Inspection Convention/Pharmaceutical Inspection Co-operation Scheme. GMP Annex. 1 Revision 2008, Interpretation of most important changes for the Manufacture of Sterile Medicinal Products.

January 2010.

17.8 World Health Organization. Technical Report Series, No. 961, 2011 Annex 3, good manufacturing. practices for pharmaceutical products: main principles y Annex 6, WHO good manufacturing practices for

sterile pharmaceutical products. Geneva, 2011.

17.9 World Health Organization. Technical Report Series, No. 961, 2011 Annex 4, guidelines on good. manufacturing practices for blood establishments. Geneva, 2011.

17.10 World Health Organization. Recommendations for the evaluation of animal cell cultures as substrates. for the manufacture of biological medicinal products and for the characterization of cell banks. 2010.

17.11 World Health Organization. Technical Report Series, No. 924, 2004 Annex 4, guidelines on viral. inactivation and removal procedures intended to assure the viral safety of human blood plasma products.

Geneva, 2004.

17.12 U.S. Foods and Drug Administra tion. “Title 21, parts 11 & 211” Code of Federal Regulations,. Washington: Government Printing Office, 2012.

17.13 U.S. Foods and Drug Administration. Guidance for Industry Process Validation: General Principles. and Practices. Washington, January 2011.

17.14 U.S. Foods and Drug Administration. Guidance for Industry, CGMP for Phase 1 Investigational. Drugs. Washington, 2008.

17.15 ICH Q5A (R1): viral safety evaluation of biotechnology products derived from cell lines of human or. animal origin (September 1999).

17.16 ICH Q5B: Quality of biotechnological products: analysis of the expression construct in cells used for. production of r-DNA derived protein products (November 1995).

17.17 ICH Q5C: Quality of biotechnological products: stability testing of biotechnological/biological products. (November 1995).

17.18 ICH Q5D: Derivation and characterization of cell substrates used for production of. biotechnological/biological products (July 1997).

17.19 ICH Q5E: Comparability of biotechnological/biological products subje ct to changes in their. manufacturing process (November 2004).

17.20 ICH Q8 (R2): Pharmaceutical Development (August 2009).

17.21 ICH Q9: Quality Risk Management (November 2005).

17.22 ICH Q10: Pharmaceutical Quality System (June 2008).