Validation of high-performance liquid chromatography methods for pharmaceutical analysis: Understanding the differences and similarities between validation requirements of the US Food and Drug Administration, the US Pharmacopeia and the International Conference on Harmonization

摘要: One of the most critical factors in developing pharmaceutical drug substances and products today is ensuring that HPLC analytical test methods are used to analyze generate meaningful data. The US Food Drug Administration (FDA) United States Pharmacopeia (USP) have each recognized importance this development process separately increased validation requirements recent years. A third source, International Conference on Harmonization (ICH), has added that, when combined with previous two sources, led three different sets leaving industry a state confusion. This paper written clear up confusion over presented by these sources.