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.