Guidance for Industry : Q9 Quality Risk Management – Free PDF Download




Risk management principles are effectively utilized in many areas of business and government
including finance, insurance, occupational safety, public health, pharmacovigilance, and by
agencies regulating these industries. Although there are some examples of the use of quality risk
management in the pharmaceutical industry today, they are limited and do not represent the full
contributions that risk management has to offer. In addition, the importance of quality systems
has been recognized in the pharmaceutical industry, and it is becoming evident that quality risk
management is a valuable component of an effective quality system.

It is commonly understood that risk is defined as the combination of the probability of
occurrence of harm and the severity of that harm. However, achieving a shared understanding of
the application of risk management among diverse stakeholders is difficult because each
stakeholder might perceive different potential harms, place a different probability on each harm
occurring and attribute different severities to each harm. In relation to pharmaceuticals, although
there are a variety of stakeholders, including patients and medical practitioners as well as
government and industry, the protection of the patient by managing the risk to quality should be
considered of prime importance.


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