1. ICH guidance on quality of biotechnology/biological products: derivation and characterization of cell substrates used for production of biotechnical/biological products, September 21, 1998. Available on-line at:
http://www.fda.gov/cber/guidelines.htm
.
2. ICH: final guideline on quality of biotechnological products: analysis of the expression construct in cells used for production of r-DNA derived protein products, February 1996. Available on-line at:
http://www.fda.gov/cber/guidelines.htm
.
3. ICH guidance on specifications: test procedures and acceptance criteria for biotechnological/biological products, August 18, 1999. Available on-line at:
http://www.fda.gov/cber/guidelines.htm
.
4. ICH Guidance for Industry Q1A (R2), stability testing of new drug substances and products, November 20, 2003. Available on-line at:
http://www.fda.gov.cber/guidelines.htm
.
5. ICH guidance on viral safety evaluation of biotechnology products derived from cell lines of human or animal origin, September 24, 1998. Available on-line at:
http://www.fda.gov/cber/guidelines.htm
.