HPLC Related Substances

From a Compliance perspective, must the batch being used for a Related Substances method validation be within the proposed spec for all the impurities? Is it ok to go ahead with validation if one of the impurities is at a level that will be above the specification?

Is it cGMP compliant to have HPLC Chromatograms for reference, to refer later during analysis of the same product?

Dear Michael,

Though the validations is performed for the methods it is always advisable to be compliant to the regulatory norms. Generally the validation is performed on the submission batches and these batches should be passing all the criteria’s set in the specification for the product.