Updation of pharmacopoeia specification for related substances

HI,

what should we do ?

e.g. if a product having specification of only single max imp of 0.10% & total of 1.0% impurity & its impurity profile spec is revised in updated pharmacopoeia with some known impurities and we have checked the present manufacturing batches & found complying as per current pharmacopoeia. however, when we verified its sample from the ongoing stability and found OOS in one of the impurity with new spec whereas passing with older spec . then how to handle the situation? should stop the stability and recall or to continue with the same older specification or by any other means??

Hi,

What is the limit of the known impurity. If it is 0.10% the results at initial must pass your revised specification.

[quote=kudeshia]HI,

what should we do ?

e.g. if a product having specification of only single max imp of 0.10% & total of 1.0% impurity & its impurity profile spec is revised in updated pharmacopoeia with some known impurities and we have checked the present manufacturing batches & found complying as per current pharmacopoeia. however, when we verified its sample from the ongoing stability and found OOS in one of the impurity with new spec whereas passing with older spec . then how to handle the situation? should stop the stability and recall or to continue with the same older specification or by any other means??[/quote]

[quote=peyyeti.veeru]Hi,

What is the limit of the known impurity. If it is 0.10% the results at initial must pass your revised specification.[/quote]

hi, it is just a assumed case, consider 0.3 as known.

Hi, if acceptance limit is greater then 0.1% you can continue your stability testing.

[quote=kudeshia]HI,

what should we do ?

e.g. if a product having specification of only single max imp of 0.10% & total of 1.0% impurity & its impurity profile spec is revised in updated pharmacopoeia with some known impurities and we have checked the present manufacturing batches & found complying as per current pharmacopoeia. however, when we verified its sample from the ongoing stability and found OOS in one of the impurity with new spec whereas passing with older spec . then how to handle the situation? should stop the stability and recall or to continue with the same older specification or by any other means??[/quote]

I just want an update if there is already an answer on how to handle this situation. thank you very much.