Dear Forum Members,
We are designing in-use stability study protocol for one of our Eye Drop
In this regard I am referring EMEA guide “NOTE FOR GUIDANCE ON IN-USE
STABILITY TESTING OF HUMAN MEDICINAL PRODUCTS” dated 1 March 2001.
As per this guide, appropriate physical, chemical and microbial properties
of the product susceptible to change during use should be monitored.
My question is which test parameters are studied during in-use stability
testing for microbial properties and at what interval? The product is
sterile and to be used within 28days after opening.
Share your valuable comments.
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