“X” product contains 31 impurities in total, 23 are process impurities & 8 are degradation impurities. Performing complete validation for degradation impurities and only specificity for process impurities is acceptable? Also, since process impurities are more, overlapping (No separation shows in specificity parameter) of process impurities is acceptable? Kind requests you all to provide your valuable response with any of documented/guideline proof.
Raj Kumar Vodnala
Regulatory Affairs Professional.