hello,
I would like to ask you if the risk assessment is enough if I have bought API substance from the manufacturer who manufactured it according to old monograph if the new monograph is coming into force soon f.i. the new monograph is valid from April 2013, I want to use the substance to manufacture my medicinal product in June 2013, but I have some of that API substance in stock because I bought it in December 2012 and the expiry date for it is December 2013? Do I need t odo some analysis to prove the risk assessment?
Chris
When a monograph is revised, only and generally, the specification limit will be changed. Check the test results of your API against your new monograph. if all tests are within the limits, you can simply use it for your formulations. If any new test is included in your new monograph, then, it is enough to test the new parameter. But, if there any OOS (as per new spec), you need to prove that the OOS cannot alter the quality of your finished product.
VEERRAJU