– Methods Validation Now that are our analytical instruments have now been quali

Question

– Methods Validation Now that are our analytical instruments have now been qualified, they are ready to be used and validated as part of our methods. 1. Go to: http://www.ich.org/ 2. On the work products tab, select “ICH guidelines”. 3. Select Quality Guidelines 4. Select Q2 Analytical Validation 5. Read Q2(R1) on Validation of Analytical Procedures: Text and Methodology, starting with Part II, and briefly describe and differentiate the eight major characteristics or parameters that are considered in analytical method validation, e.g. from specificity to robustness. This a biotechnology course – Methods Validation Now that are our analytical instruments have now been qualified, they are ready to be used and validated as part of our methods. 1. Go to: http://www.ich.org/ 2. On the work products tab, select “ICH guidelines”. 3. Select Quality Guidelines 4. Select Q2 Analytical Validation 5. Read Q2(R1) on Validation of Analytical Procedures: Text and Methodology, starting with Part II, and briefly describe and differentiate the eight major characteristics or parameters that are considered in analytical method validation, e.g. from specificity to robustness. This a biotechnology course – Methods Validation Now that are our analytical instruments have now been qualified, they are ready to be used and validated as part of our methods. 1. Go to: http://www.ich.org/ 2. On the work products tab, select “ICH guidelines”. 3. Select Quality Guidelines 4. Select Q2 Analytical Validation 5. Read Q2(R1) on Validation of Analytical Procedures: Text and Methodology, starting with Part II, and briefly describe and differentiate the eight major characteristics or parameters that are considered in analytical method validation, e.g. from specificity to robustness. This a biotechnology course

Explanation / Answer

The eight major characteristics that are considered in analytical method validation are:-

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