ICH Q2 Analytical Method Validation Compliance Testing
The ICH Q2 Guideline provides a framework for pharmaceutical manufacturers to ensure that analytical methods used in drug development and manufacturing are robust, accurate, and reliable. This service focuses on the validation of analytical methods as per ICH Q2 requirements, which is critical for regulatory compliance.
The process involves several stages: method development, optimization, qualification, and validation. During this testing, we assess various aspects such as specificity, linearity, precision, accuracy, robustness, and耐用性 <|im_start|><|im_start|>⚗️
