we are developing drug substance in r&d . we require SOP for that kindly help.
As far as I know there is no particular SOP for process development. Actually after process optimization, development report to be prepared based on R&D lab experiments and analytical data.
Dear @rajendra10
I agree with Jayaram, development will be product specific, so if you are developing a product, this process may or may not be applicable to your future developments. So basically development is a trial and error process which leads you to a final robust formula. There wont be a particular SOP for development.