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Abstract
Cohesive Journal of Microbiology & Infectious Disease
Viable Monitoring During the Filling of a Terminally Sterilized Pharmaceutical Product-Risk Based Approach
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Open or Close Ahmed Assem*
Tabuk Pharmaceuticals, Saudi Arabia
*Corresponding author: Ahmed Assem, Tabuk Pharmaceuticals, Saudi Arabia
Submission: July 21, 2017 ; Published: July 18, 2018
ISSN: 2578-0190 Volume2 Issue1
Abstract
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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