Analytical Method Validation
Analytical method validation is a systematic process of establishing documented evidence that an analytical method is suitable for its intended use in measuring the identity, purity, strength, and/or content of a substance. Governed by regulatory agencies (FDA, ICH) and industry standards (USP, EP), validation ensures that analytical methods are reliable, accurate, and suitable for quality control in pharmaceutical, food, chemical, and environmental industries. Method validation is mandatory for regulatory submissions and is a cornerstone of good manufacturing practice (GMP).
Rekod sumber
Petikan disalin secara verbatim daripada rekod sumber kaedah. Tiada pengesahan peringkat tuntutan disimpulkan daripadanya.
- Food and Drug Administration. (2015). Analytical Procedures and Methods Validation: Chemistry, Manufacturing, and Controls Documentation. FDA Guidance for Industry. · URL
- International Council for Harmonisation. (2005). ICH Q2(R1) Validation of Analytical Procedures: Text and Methodology. ICH Harmonised Tripartite Guideline. · URL
- United States Pharmacopeia. (2021). Chapter <1225> Validation of Compendial Procedures. USP 44-NF 39. · URL
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Kaedah berkaitan
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