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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

  • 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

DOI: 10.31031/CJMI.2018.02.000527

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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