Analytical method validation in R&D

Can analytical method validation be performed after COA (Certificate of analysis) generation of final batch taken for stability study OR Is it necessary to complete AMV before initial month stability study?

It is necessary to satisfactorily complete Analytical method validation of the product before conducting initial analysis as a part of “Batch Release” and also before first batch samples are kept for stability studies. This is to ensure that the initial analytical results of the batch undergoing stability studies are accurate and reliable.

Although initial Analytical method validation is done by R&D, however, when the Analytical method is transferred from R&D to QC Laboaratory as a part of Technology Transfer (Analytical), this must be validated as explaind in my previous reply.


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