Should a finished product R&D site perform full validation of Drug substance test methods for In-house (chromatographic) methods (already validated by Drug substance manufacturer) for transfer of methods to an outsourced finished product testing site? What parameters should be validated in case full validation is not required?
The QC lab at dosage form unit does NOT NECCESSARILY requires to perfom entire validation for API methods for inhouse developed chromatographic methods. However as part of method transfer, the receving lab (ie) finished producttesting sites has to ensure ATLEAST the following analytical parameters : SPECIFICITY, PRECISION & ACCURACY.
Thank you.
We need to complete transfer of API methods for an outsourced API - our analytical laboratory has not done method validation for In-house methods and the API manufacturer has shared validation reports which are more than five years old. So, the samples for same validation batches are not available to share with the receiving unit. So, how can method transfer be completed in such a case - should our analytical lab validate or verify the methods and then transfer the same?
Specificity and Precision for assay
Specificity , LOQ and Precision for Impurities test
LOD for Limit tests.
Regards,
Bujji Reddy Kanchi