2World Health Organization.WHO Technical Report Series No.908,Application of Hazard Analysis and Critical Control Point(HACCP)methodology to Pharmaceuticals[S].2003.
3INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE.ICH HARMONISED TRIPARTITE GUIDELINE Q9,Quality Risk Management[S].2005-11-09.
4EUROPEAN COMMISSION.EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use Annex 20,Quality Risk Management[S].2008-02-14.
6International Organization for Standardization.ISO 2001,Quality Management Principles[S].2001.
7National Advisory Committee on Microbiological Criteria for Foods.Hazard Analysis and Critical Control Point Principles and Application Guidelines[S].1997-08-14.
