КРИТЕРИИ И ТРЕБОВАНИЯ ДЛЯ ОЦЕНКИ МЕТОДОВ ИСПЫТАНИЙ В АНАЛИТИЧЕСКОЙ ХИМИИ И ИХ ПРИМЕНЕНИЯ: ТРЕБОВАНИЯ-КРИТЕРИИ ОЦЕНКИ МЕТОДОВ ИСПЫТАНИЙ В АНАЛИТИЧЕСКОЙ ХИМИИ И ИХ ПРИМЕНЕНИИ

To comply with ISO/IEC 17025, laboratories are required to verify and validate analytical methods, evaluate measurement uncertainty, and ensure the quality of test results. However, the standard does not provide specific instructions on how to implement these requirements, leaving laboratories to seek guidance from various external sources. In addition, laboratories must often adhere to field-specific regulations such as CIR 2021/808, SANTE, AOAC, USP, and FDA—making the requirements even more complex and demanding.This book is not only intended for laboratory professionals but also for students and graduate researchers in the field of quantitative analytical chemistry. While there is a wealth of material available in English on method validation, resources in Vietnamese remain limited and are often difficult to apply in practice.To address this gap, the book is presented in both English and Vietnamese. One of its unique strengths is the inclusion of practical exercises designed to reflect real-world laboratory conditions. These exercises can be downloaded using QR codes embedded in the book, and updated versions will be made available as regulatory guidelines evolve—ensuring readers always have access to the most current information.Contents: CHAPTER 1. INTRODUCTION Explains the necessity of method validation and differentiates between method verification and validation. CHAPTER 2. BASIC STATISTICAL FUNCTIONS Introduces commonly used statistical functions and hypothesis tests in method validation. CHAPTER 3. GUIDELINES FOR METHOD VALIDATION Provides step-by-step instructions for conducting method validation in accordance with CIR 2021/808, SANTE, AOAC, USP, FDA, and other guidelines. CHAPTER 4. EVALUATION OF MEASUREMENT UNCERTAINTY Offers practical approaches for estimating and reporting measurement uncertainty. CHAPTER 5. INTERNAL QUALITY CONTROL Introduces internal quality control , including control charts and the use of quality control samples.Whether you are setting up validation procedures for your laboratory, preparing for accreditation, or conducting research in analytical chemistry, this bilingual book is a practical and up-to-date reference designed to help you both understand and apply the principles of method validation and quality assurance effectively.