Step 3: Analytical method validation
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You must validate analytical methods after their development and before routine use. If you change any parameter significantly, you must revalidate the method.
National and international standards and interpretation guides, such as those issued by the United States Pharmacopeia (USP) and the International Conference on Harmonization (ICH) organizations, specify parameters for method validation.
Agilent offers software for automated method validation with ChemStation Plus
- Supports all GxP regulations and 21 CFR Part 11
- Supports US adn European Pharmacopeias
- Offered with validation services
- Use of standard Microsoft Word as report generator for highest flexibility
- Full system automation through seamless integration into the Agilent 1200 Series LC.
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