Dear Rishabh,

Hold time studies in pharma industries is really very important. I've attached a document which contains WHO guidelines on hold time studies. I hope this will be helpful for you.

Regards,

Abhishek

Dear Rishabh,

The factors need to be consider are dependent on the formulation type as well as processing step. All the factors which can effect the intermediate as finished product quality should be considered for hold time study in a particular processing step. Finally the quality of the intermediate or finished product should be assured with relevent test.

Regards

Srimanta