Viable Monitoring During the Filling of a Terminally Sterilized Pharmaceutical Product-Risk Based Approach-Crimson Publishers

Viable Monitoring During the Filling of a Terminally Sterilized Pharmaceutical Product-Risk Based Approach by Ahmed Assem in Infectious Disease Open Access Journals_Crimson Publishers

This article addresses a risk based approach to establish a routine monitoring program of viable (I.e. microorganisms) in a controlled environment used to produce pharmaceutical products that are intended to be terminally sterilized. Current applicable quality system regulation & GMP require appropriate environment to be established, maintained and monitored for the manufacturing of the terminally sterilized pharmaceutical meanwhile the appropriate environmental monitoring plan is not clearly specified & a risk based approach will be a valuable tool to design a suitable program

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