How to handle atypical Environment Monitoring Trend in Clean Rooms of Sterile Formulation Units?

16 June 2020 0 3K Report

Dear Folks,

I am working in a sterile formulation unit (ophthalmic) in India. I need your suggestions to prepare the standard procedure for handling of atypical trend in the environment monitoring (viable) of clean rooms. We have establish the alert level for each classification and we are calculating percent contamination recovery rate as suggested in USP 42 General Chapter 1116. Currently we are not having any OOT as we take immediate action at Alert Level.

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