Stability Studies & Self Inspection
Stability of Finished Products is carried out as per ICH Guidelines. This includes Short Term Accelerated Stability Studies at elevated, Room Temperatures and Long Term Stability Studies at Room Temperatures for upto 6 months after Expiry. Shelf Life of Product is monitored through Stability Study Data.
Self inspections are carried out with set frequency with the help of check list. Observations during self inspection are brought to notice of heads of respective user department and corrective action is taken. Q.A. is responsible to check that compliances on self inspection are carried out.