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Abstract

Cohesive Journal of Microbiology & Infectious Disease

Implementation of Quality Risk Management for Manufacturing of a Non-Sterile Pharmaceutical Product- Case study

  • Open or Close Ahmed Assem*

    MBA, Tabuk pharmaceuticals, Saudi Arabia

    *Corresponding author: Ahmed Assem, MBA, Tabuk pharmaceuticals, Saudi Arabia, Email: ahmedasemelu@hotmail.com

Submission: January 16, 2018; Published: April 06, 2018

DOI: 10.31031/CJMI.2018.01.000514

ISSN: 2578-0190
Volume1 Issue3

Abstract

This article will address a model for implementation of quality risk management for the manufacturing of a non-sterile product through a real case. The risk addressed in the article is the microbiological contamination and the procedure followed was Failure Mode Effect Analysis (FMEA) mainly. It can be used by pharmaceutical scientist to evaluate the possible causes of microbiological contamination of their products and will show how to evaluate the risks and describe a monitoring plan based on the associated risks.

keywords:Pharmaceutical microbiology; Quality risk management; Pharmaceutical manufacturing; Microbial contamination

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