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Comments on retrospective analytical assay validation

Hi all,
I am thinking about doing retrospective analytical assay validation for the analysis of finished products that are already in market and is not validated. Now, I got the responsibility to validate them in a minimum budget. As most of them are compendial methods. I am thinking to study only accuracy and precision of the methods. I am thinking to take the history of the analytical records. For the study of history I am thinking to chose the analytical datas of the raw materials that were conducted inside the particular laboratory. For calculating the accuracy I got doubt.

I request all to give some ideas about the standard that I need to consider the accuracy in term of percentage. (say 99.5%). I am thinking about the analytical report send by the supplier as the standard. But that is also not the standard one as there may be some deteriotion in the purity of the materials during the transportation. I do not have idea about to adjust the loss of potency. So, I need help from you guys about the standard that I should take to make comparison between the assay obtained after analysis and the assay send by the supplier.

But still I think that if i consider the same standard that will only minimize the accuracy and still if pass the limit of accuracy then the method can be validated and could be considered as reliable and meet the intended purpose.

Please comment about this and provide any suggestions or recommendations.

dear daprawan,
in my opinion i most trust the analytical data from my own laboratory test, because there’s some case that the analytical data from the supplier of raw material can be manipulated by them. my company always happen case like that. the result of the analytical data from my company and the supplier in some case different. and about the accuracy standard i think you should see the standard that had been regulated like in the Pharmacopeia or other regulation. in my country the accuration shoul be > 98 % for the raw material and > 99 % for the finished product.:slight_smile:

I am agreed with Rika, but apart form accuracy and precision you have to prove specificity, stability indicating method and solution stability. Boz compendial method is use as guideline,it doesn’t talk about quality of raw material or API used in formulation.