As we know that :
Any significant change to the system/processing equipment / process / services /Utelities triggers revalidation such as :
Change in source of API or major component /
Change in batch size
trends of stability data,
trends of annual product review
or any other changes that may affect the product quality
So, how to evaluate the extent or the level of defining as term “significant” in these above situations?
cite with examples?
Also, How the validation need , evolves out risk assessment?and in all cases we need to extraploate Risk assessment.