1. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. Q1A(R2): Stability testing of new drug substances and products; 2003.
2. PQRI Stability Shelf Life Working Group.
http://www.pqri.org/commworking/minutes/pdfs/dptc/sslwg/Addl/2007_MBSW.pdf
. Additional presentations from SSL WG are available at
http://www.pqri.org/structure/wg.asp#sslwg
, 2007; Accessed 27 March 2012.
3. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use. Q6A: specifications: test procedures and acceptance criteria for new drug substances and new drug products: Chemical Substances; 1999.
4. International Organization for Standardization. ISO 2859. Sampling procedures for inspection by attributes, parts 0–4. ISO 2859-0:1995; ISO 2859-1:1999; ISO 2859-2:1985; ISO 2859-3:1991; ISO 2859-4:2002.
http://www.iso.org/iso/iso_catalogue/catalogue_tc/catalogue_detail.htm?csnumber=7865
. Accessed 18 June 2012.
5. International Organization for Standardization. ISO 3951:1989. Sampling procedures and charts for inspection by variables for percent nonconforming.
http://www.iso.org/iso/iso_catalogue/catalogue_tc/catalogue_detail.htm?csnumber=9602
. Accessed 18 June 2012.