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The biopharmaceutical industry has been working recently to attend the suggestion of international standards to structure a Risk Assessment Quality System. For example, the ICH (International Conference on Harmonization) through the Q9 guide, recommends the use of risk analysis tools to support the risk management process. However, methodologies for identification and analysis of failures and deviations proposed in this guide are focused mainly for risk management at specific targets, such as processes, noncompliance, equipment, infrastructure, etc., and is commonly necessary to apply independently more than one tool for analysis and identification of risk.

Integration methodologies for risk management in the biopharmaceutical industry