Hello,
Should I re-validate the whole production process if I change one inactive ingredient to another, very similar?
e.g.
Sodium Starch Glycolate, type A --> Sodium Starch Glycolate, type C
(about 5 kg in a 200 kg batch; tablets).
Dear valtschaq,
it is difficult to say from the distance if a complete revalidation is needed. I think the right way is to decide through a risk assessment, which should include the functionality of the ingredient in the formulation, how critical historically is the parameter influenced by this ingredient (if it acts as a disintegrant, and disintegration time has never exceeded 50% below maximum spec, there is no issue), and the rationale why it was changed. A confirmation batch comparing with historical values will do no harm.
Best regards
Alfred