ASPECTS OF VALIDATION IN HPLC METHOD DEVELOPMENT FOR PHARMACEUTICAL ANALYSIS – COMPARISON OF VALIDATION REQUIREMENTS BY FDA, USP AND ICHAbstract
The most important factor in developing pharmaceutical drug substances and drug products today is ensuring that the HPLC analytical test methods that are used to analyze the products generate reliable, reproducible and meaningful results. The US Food and Drug Administration (FDA) and United States Pharmacopeia (USP) have each documented the importance of this to the drug development process and have separately increased validation requirements in recent years. A third source, the International Conference on Harmonization (ICH), has added requirements that, when combined with the previous two sources, have led to three different sets of validation requirements leaving us in ambiguity. This paper gives us a clear understanding over the validation requirements that should be satisfied by FDA, USP and ICH.
R. Suresh*, Sree V. J. Anarthanan, R. Manavalan and K. Valliappan
Department of Pharmacy, Faculty of Engineering & Technology, Annamalai University, Annamalai Nagar, Tamilnadu, India
24 July, 2010
11 October, 2010
07 November, 2010
01 December, 2010