Glossary
Risk Assessment
What is Risk Assessment?
Risk assessment is the systematic process of identifying, evaluating, and estimating the levels of risk involved in a specific situation, activity, or process. It involves:
- Recognizing potential sources of harm or adverse effects.
- Determining the likelihood and potential severity of these hazards causing harm.
- Comparing the estimated risks against established criteria to determine their significance.
- Deciding on appropriate measures to eliminate or mitigate the risks to an acceptable level.
What are the key steps involved in risk assessment process?
The key steps include risk identification, risk analysis (assessing the severity and likelihood of identified risks), risk evaluation (comparing risks against risk criteria), and risk control (implementing measures to mitigate risks).
What regulatory guidelines govern risk assessment in pharma?
 Key regulatory guidelines include the International Council on Harmonization (ICH) Q9, which outlines principles for quality risk management, and various FDA guidelines that emphasize the importance of risk assessment in pharmaceutical development and manufacturing.
