Quality Risk Management

Uma lista de guides que podem ajudar muito no processo de Quality Risk Management, abaixo esta a lista, para acessar os links click abaixo.

Lista Quality Risk Management

1. US FDA document "Pharmaceutical cGMPs forthe 21st Century: A Risk-Based Approach";
2. ICH Q9 Quality RiskManagement guideline;
3. ISO/IEC Guide 73:2002 - Risk Management - Vocabulary -Guidelines for use in Standards;
4. ISO/IEC Guide 51:1999 - Safety Aspects -Guideline for their inclusion in standards;
5. AS/NZS 4360:2004 - Risk Management;
6. WHO Technical Report Series No 908, 2003, Annex 7 Application of HazardAnalysis and Critical Control Point (HACCP) methodology to pharmaceuticals;
7. ENISO 14971: Application of risk management to medical devices;
8. PharmaceuticalDevelopment (ICH Q8) and Annex (ICH Q8(R1);
9. FDA Guidance for Industry PAT -A Framework for Innovative Pharmaceutical Development, Manufacturing and Quality Assurance;
10. Pharmaceutical Quality Systems (ICH Q10);
11. FDA Guidancefor Industry Quality Systems Approach to Pharmaceutical cGMP Regulations.

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