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).
원본 기록
방법의 원본 기록에서 그대로 복사된 인용입니다. 이로부터 수준별 검증이 추론되지 않습니다.
- 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
큐레이션된 주장
각각 자체 평가와 함께 증거 원장에 유지된 주장입니다.
원장에 주장 평가가 없는 경우 이 보기에서는 주장 평가를 만들지 않습니다.
관련 방법
방법 그래프에서 생성되었으며 기계가 제안한 관계로 표시됩니다 — 증거 주장이 추론되지 않습니다.