i have found couple of examples of design and process fmea for engineering; and i believe that it is mandatory part for devices as well...
can anyone pl. provide an example document for pharmaceutical product development and optimization/manufacturing.
thank you for the reference, its a good reference; though, i checked out the book (on google books) ....FMEA ... its more from a operations/manufacturing point of view.As it is some way outside my experience all I can suggest is something like this:-
http://www.amazon.co.uk/Pharmaceuti...+process+development+and+process+optimization