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what is difference between method validation and method
verification
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Answer / nilesh l patel
method validation is document evidance that method is accuurate for intended use it gives accurate and reproducible results.in method validation we check bellow mention parameters .1>specficity 2>pricision (repetibility and intermidiate precision),3> LOD & LOQ BY regration method or SN ratio method 4>robousness 5>rogudness.
while
method trancfer is document evidence that whatever method is developed by adl deparment is applicable to qc PLANT for comercile purpose. for this qc checks difference of two laboratory results ,it should NMT 2% RSD IN ASSAY and also limitis given in TTVP for Related substances.
| Is This Answer Correct ? | 20 Yes | 16 No |
Answer / avyaya prabhu
Method will be validated if it is newly developed.
Where as compendial method will be verified in a laboratory for suitability,to establish a documental evidence that the method is performing as intended.
Method validation will be conducted with all parameters like Specificity, Accuracy,Precision, Linearity, Robustness & LOD LOQ.
Where as method verification will be conducted with performance parameters only like Specificity, Accuracy, Precision and Robustness.
| Is This Answer Correct ? | 5 Yes | 2 No |
Method Validation: It is performed either when method is non-compendial or any changes has been made in a compendial method. only few parameters shall be validated if any changes has been in a compendial method.
Method verification: It is performed when method is compendial and only few parameters have to be checked as before implementing these method in a monograph, pharmacopoeia usually validate the method. only thing to be checked is the suitability of the method.
Thank you
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