Analytical Method Validation
(การตรวจสอบความถูกต้องของวิธีวิเคราะห์)
Definition
Analytical Method Validation (การตรวจสอบความถูกต้องของวิธีวิเคราะห์) Hard Skill
The process of ensuring that an analytical method used in testing is reliable, accurate, and consistent for its intended purpose, following established guidelines and criteria.
Expertise Level
Level 1
Basic
1. Understands fundamental concepts of analytical method validation.
2. Familiar with common validation parameters such as accuracy and precision.
3. Can assist in basic validation experiments under supervision.
Level 2
Intermediate
1. Performs method validation including accuracy, precision, specificity, and linearity.
2. Analyzes validation data and identifies deviations or errors.
3. Prepares validation protocols and reports according to regulatory standards.
Level 3
Advanced
1. Designs comprehensive validation strategies for complex analytical methods.
2. Ensures full compliance with international regulatory guidelines (e.g., ICH, USP).
3. Leads troubleshooting and optimization of methods based on validation outcomes.
