SOP for Analytical Method Validation
This SOP outlines the procedure for validating analytical methods to ensure accuracy, precision, specificity, and reproducibility as per regulatory and scientific standards.
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Analytical method validation is a fundamental requirement in pharmaceutical quality control and quality assurance. This SOP describes the standardized approach to perform validation of analytical methods used for testing raw materials, intermediates, and finished products. The document covers the validation parameters such as accuracy, precision, specificity, linearity, range, detection limit, quantitation limit, robustness, and system suitability. The objective is to confirm that the method is suitable for its intended purpose and consistently produces reliable and reproducible results under defined conditions, in accordance with ICH Q2(R1) guidelines and applicable regulatory expectations.

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