Quality Risk Management References
Status: Completed
The Quality Risk Management Working Group has compiled a series of references to assist with QrM. These are listed below.
If you encounter a resource which could make a good addition to this table, we encourage you to contact us.
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Resource |
URL |
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ICH Q9: Quality Risk Management. Fed. Reg. 71(106) 2006: 32105–32106 |
http://www.fda.gov/ or http://www.ich.org/
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ICH Q10: Pharmaceutical Quality System. Fed. Reg. 74(66) 2009: 15990–15991 |
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EU Guide to GMP –Chapter 1 Quality Management |
http://ec.europa.eu/health/files/eudralex/vol-4/vol4-chap1_2012-06_en.pdf |
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EU Guide to GMP –Annex 20 Quality Risk Management |
http://ec.europa.eu/health/files/eudralex/vol-4/pdfs-en/2008_02_12_gmp_annex20_en.pdf |
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WHO GUIDELINE ON QUALITY RISK MANAGEMENT |
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ISO 31000:2009 Risk management -- Principles and Guidelines |
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ISO/TR 31004:2013 Risk management -- Guidance for the implementation of ISO 31000 |
http://www.iso.org/iso/home.html
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ISO Guide 73:2009 - Risk Management – Vocabulary - Guidelines for Use in Standards. International Organization for Standardization: Geneva, Switzerland, 2009 |
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ISO 14971:2007 Application of Risk Management to Medical Devices. International Organization for Standardization: Geneva, Switzerland, 2007 |
http://www.iso.org/iso/home.html
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Australian Regulatory Guidelines for Biologicals. Appendix 11 - Risk Management. Australian Therapeutics Goods Administration |
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Medicines and Healthcare Products Regulatory Agency (MHRA): Good Manufacturing Practice (GMP) - Quality risk management: Frequently asked questions |
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Quality Risk Management Implementation of ICH Q9 in the pharmaceutical field an example of methodology from PIC/S |
http://www.picscheme.org/pdf/65_psinf012010exampleofqrmimplementation-copy1.pdf
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Global Harmonization Task Force (GHTF) Implementation of Risk Management Principles and Activities within a Quality Management System |