Валидация фармацевтических аналитических методов в соответствии с ICH Q2(R2), USP и Ph. Eur.: Полное руководство по валидации аналитических методов в фармацевтической промышленности – пояснения к рекомендациям ICH Q2(R2), USP <1225> и Ph. Eur.

Validation of Pharmaceutical Analytical Methods according to ICH Q2(R2), USP, and Ph. Eur.The ultimate pharmaceutical analytical method validation guide for GMP-compliant laboratories. Covers ICH Q2(R2), USP <1225>/<1226>/<1224>, and Ph. Eur. 2.2.46 with step-by-step instructions for Specificity, Accuracy, Precision, LOD, LOQ, Linearity, Range, Robustness, and System Suitability. Includes HPLC and GC practical examples, acceptance criteria, calculation methods, and regulatory compliance strategies for FDA, EMA, and ANVISA.Ideal for Quality Control (QC), Quality Assurance (QA), regulatory affairs, and R&D scientists. Learn how to prepare validation protocols, execute method verification, and meet audit requirements with confidence. A must-have reference for ensuring analytical accuracy, data integrity, and global regulatory compliance in pharmaceutical analysis.