sir our one product passes 3 months accelerated stability study and 12 months real time study , what will be the shelf life of the product as per ICH .
Pls confirm , and how it is calculated and from where it has been written in ICH
Regards
KAJAL
Look for the guidance in ICH Q1E. If the 6M accelerated data also complies and the 12 M real time study is available, a shelf life of 24 months can be allotted to the product. If the 6 M Accelerated data fails, look for the stability of sample kept at intermediate (30/65) condition.