MBA, Tabuk pharmaceuticals, Saudi Arabia
*Corresponding author: Ahmed Assem, MBA, Tabuk pharmaceuticals, Saudi Arabia, Email: firstname.lastname@example.org
Submission: January 16, 2018; Published: April 06, 2018
ISSN: 2578-0190 Volume1 Issue3
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