Implementation of Quality Risk Management for Manufacturing of a Non-Sterile Pharmaceutical Product- Case study by Ahmed Assem in Cohesive Journal of Microbiology & Infectious Disease
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