**Project and Enterprise Risk Management at the California Department of Transportation**

Pedro Maria-Sanchez

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industry. Clear and simple. PDA/DHI.

/ International standard 608121985.

internationale / International standard 1025

Manufacturing Sites — A Pilot Risk Ranking Model.

Series, No. 908. Annex 7.

[1] FDA (2004) Pharmaceutical CGMPS for the 21st century - A risk-based approach. Final report. [2] ICH (2005) Quality risk management. ICH Harmonised Tripartite GuidelineGuideline Q9. [3] ICH (2008) Pharmaceutical quality system. ICH Harmonised Tripartite GuidelineQ10. [4] ICH (2009) Pharmaceutical development. ICH Harmonised Tripartite GuidelineQ8 (R2). [5] ICH (2011). Development and Manufacture of Drug Substances (Chemic al Entities and

[6] Vesper, J. L. (2006) Risk assessment and risk management in the pharmaceutical

[7] CEI/*IEC (1985)* Techniques d'analyse de la fiabilité des systèmes. Procédure d'analyse des modes de défaillance et de leurs effets (AMDE) / Analysis techniques for system reliability. Procedure for failure mode and effects analysis (FMEA). Norme internationale

[8] WHO (2003) Hazard and risk analysis in pharmaceutical products. Technical Report

[9] CEI/IEC (1990) Analyse par arbre de panne (AAP) / Fault tree analysis (FTA). Norme

[10] FDA (2004) Risk-Based Method for Prioritizing CGMP Inspections of Pharmaceutical

Biotechnological/Biological Entities). Draft Consensus Guideline Q11.

**Author details** 

**12. References** 

*JBF - GMP Consultant, Spain* 

Jordi Botet

Additional information is available at the end of the chapter

http://dx.doi.org/10.5772/51442
