Hi is it required to include the Impurities which are used for cut off study/ absence study or single time analysis. For instance, Impurity J is carrying from starting materials which was shown the fate in N-1 / N-2 Stage and same by analysing three consecutive batches.The report submitted.. is impurity J COA and structural elucidation data need to be submitted? Kindly clarify… We performed SM and Intermediates method validations and same were included in DMF.. Are impurities in Starting materials, Intermediates COAs and Structural elucidation need to be submitted? Kindly clarify…
Hi, since these impurities standards were used for analytical validations even for more simple validations applied to carryover studies, the COA and structural elucidation need to be available, although the regulatory agency may not require them to be included in the DMF. Some consider this as part of GMP compliance and in such case the characterization could be kept in house and provided if requested. I advise you to contact the specific regulatory agency to get clarification on their preferred approach.
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Hi is it required to include the Impurities which are used for cut off study/ absence study or single time analysis. For instance, Impurity J is carrying from starting materials which was shown the fate in N-1 / N-2 Stage and same by analysing three consecutive batches.The report submitted.. is impurity J COA and structural elucidation data need to be submitted? Kindly clarify…
We performed SM and Intermediates method validations and same were included in DMF.. Are impurities in Starting materials, Intermediates COAs and Structural elucidation need to be submitted?
Kindly clarify…
Hi, since these impurities standards were used for analytical validations even for more simple validations applied to carryover studies, the COA and structural elucidation need to be available, although the regulatory agency may not require them to be included in the DMF. Some consider this as part of GMP compliance and in such case the characterization could be kept in house and provided if requested. I advise you to contact the specific regulatory agency to get clarification on their preferred approach.
@@FernandaWaechter thank you very much for your swift reply.