Origin and generic dugs

[nihal]

Hi,
When we compare type and limit of related impürities in drug product
specifications , what types of differences should be mostly involved in origin drug product spesifications and generic drug product spesifications? I have no found enough information comperatively in ICH and FDA guidances.
Thank you for now.

[maris]

Go to http://www.fda.gov/cder/guidance/2452fnl.htm

FDA gives you a very clear regulations