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

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

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