Often seen as a burden, Quality Risk Management (QRM) is actually a powerful tool to drive compliance, control and improvement.
Many medium and smaller pharmaceutical organisations, particularly those with virtual business models (i.e. office based without any production or storage facilities) have struggled in the past to comply with this regulatory expectation.
Only recently have inspectors started to review how organisations manage risk through documented risk assessments and formal risk registers.
Larger global organisations have fully embraced QRM, with strong inter- site links to share equivalent risk mitigation on similar processes and systems.
This article is not intended to replicate the content of ICHQ9 and other valuable information sources on this subject.
It is primarily designed to shed a little more light on the practical aspects of generating a comprehensive risk assessment for businesses and operational sites, regardless of size, complexity, markets supplied and GxP compliance.
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