1 GAMP Forum, Good Automated Manufacturing Practice (GAMP) Guide Version 4 , International Society for Pharmaceutical Engineering, Tampa, FL, 2001.

2 Institute of Electronic and Electrical Engineers, Software Engineering Standards 2003 Collection , Institute of Electronic and Electrical Engineers, Piscataway, NJ, 2003.

3 N.Dyson, Chromatographic Integration Methods , 2nd edn, Royal Society of Chemistry, Cambridge, 1998.

4 A.Felinger, Data Analysis and Signal Processing in Chromatography , Elsevier, Amsterdam, 1998.

5 R.D.McDowall, LC-GC Eur. , 1999, 12, 568 578.

6 R.D.McDowall, in: Analytical Chemistry in a GMP Environment A Practical Guide , J.M.Miller and J.B.Crowther (eds) Wiley, New York, 2000, 395 421.

7 C.Burgess, D.G.Jones and R.D.McDowall, LC-GC Int. , 1997, 10, 791 795.

8 United States Pharmacopeial Convention Inc., United States Pharmacopoeia 28 , United States Pharmacopeial Convention Inc., Rockville, MD, 2004.

9 European Pharmacopoeia, European Pharmacopoeia , Strasbourg, 2003.

10 C.L.Burgess, in: Development and Validation of Analytical Methods , C.L.Riley and T.W.Rosanske (eds), Pergamon Press, Oxford, 1996, 352.

11 R.J.Davis, in: Development and Validation of Analytical Methods , C.L.Riley and T.W.Rosanske (eds), Pergamon Press, Oxford, 1996, 352.

12 US Food and Drug Administration, Fed. Reg. , 1978, 41, 45076.

13 US Food and Drug Administration, Pharmaceutical cGMPs for the 21st Century: A Risk-Based Approach , 2002.

14 US Food and Drug Administration, Fed. Reg. , 1978, 43, 45077 and subsequent ammendments as listed on www.fda.gov.

15 US Food and Drug Administration, Fed. Reg. ,