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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)
90/385/EEC


Incorporates the following:
Corrigendum, August 2015