4[3]Pharmaceutical.cGMPs for The 21st Century-A risk-Based Approach Final report[EB/OL].[2007-10-10].http://www.fda.gov/cder/gmp/gmp2004/GMP_finalreport2004.html.
7[6]FDA.Guidance for Industry Quality Systems Approach to Pharmaceutical CGMP Regulations[EB/OL].[2007-10-10].http://www.fda.gov/Cder/guidance/7260fnl.htm.
10Jackelyn Rodriguez.How to Prepare for a Systems-Based Inspection-Understanding FDA's Risk-Based Inspections Approach[J].Journal of GXP Compliance,2005,9(4):14
