Monday, July 4, 2011

Validation of Compendial methods


Validation of Analytical procedures which are described in the phamacopoea are to be treated separately unlike inhouse analytical procedures. 
For in-house analytical Procedures the manufacturer must perform full validation studies such as Specificity, precision, linearity, accuracy, ruggedness and robustness for assay methods and LOD and LOD as additional tests + assay parameters for Related substances and Residual sovents methds. 
For regualtory analytical procedures method suitability should be performed instead of method validation. This should include specificity, intermediate precision and stability of the sample solution.
Care should be taken because the regulatory/ compendial analytical procedures may not be stability indicating.

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