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Risk Management

Risk management is a growing discipline within the Life Sciences industry.  With the introduction of FDA’s 21st century GMP and ICH initiatives (such as Q8 Pharmaceutical Development, Q9 Quality Risk Management, and Q10 Pharmaceutical Quality System), drug manufacturing entered a new era of risk management. There is now an expectation that organizations have a high level risk management policy in place document that defines the following:

·         areas where applicable

·         methods and tools to be used

·         associated responsibilities of both management and individuals

·         clearly stated ownership of risk decisions

·         how is risk documented and controlled

·         risk review and communication methods and timing

·         standard guides on risk ranking and acceptance

·         risk management training and resourcing

 The system is expected to support the overall risk management process as depicted by the diagram below.

Fig 1: ICH Q9 Risk Management Process Diagram

Risk Management Flow Chart

Additionally, lower level tactical procedures such as deviation management, investigations, complaints, change control, validation, computer systems, premise / equipment design & operation, supplier management, annual reviews and sampling are expected to be in place and to show that risk management is embedded into these functions (Mollah, Long & Baseman, 2013). 

Then there are the expectations corresponding to individual risk assessments, which are more detailed and tie back to the effectiveness of the policies and procedures that have been implemented. In the next post in this series, I will describe in detail what goes into a good individual risk assessment.


Nels Hackl

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