Standard Number
BS ISO 13408-7:2012
Title
Aseptic processing of health care productsAlternative processes for medical devices and combination products
Status
Current
Publication Date
28 February 2013
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)