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Cross References:
ISO 13408-1:2008
ISO 11137-2
ISO 11737-2
ISO 13485
ISO 14644
ISO 14698
ISO 14971:2007
2004/23/EC
2005/17/EC
EU Good Manufacturing Practice Directive
European Pharmacopoeia
US Pharmacopoeia
JP Pharmacopoeia
EMEA/CHMP/410869/2006
SG3/N15R8/2005
SG3/N99-10
ICH Guidance for Industry — Q9 Quality Risk Management
PDA Technical Report 22 (TR22)
PDA Technical Report 44 (TR44)
PDA Technical Report 34 (TR34)


All current amendments available at time of purchase are included with the purchase of this document.