What is stress testing?

what is stress testing ?

Stress studies shall be conducted by using approved drug substance or product…to check it’s stability by evaluating the results of purity and % of related impurities (Known /unknown), while it is interact with different parameters like…acid, base, oxidising agent, reducing agent, light and hydrolysis.

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What is the frequency of conducting these studies?

This study shall be carried out in solid and liquid states of drug .
Solid state means changes in storage temperature, % of RH. & Light.
Liquid state means drug interact with acid, base, oxidising agent…
These studies shall be carried out when there are major changes in manufacturing process like excipients/process change…And change in analytical method…