Risk assessments help companies follow regulations, maintain product quality, and protect patient safety in the regulated life sciences industry. Many traditional risk assessments rely on opinions or past experiences rather than solid technical proof. Technical evaluations provide a more accurate and data-driven way to improve risk assessments by using scientific methods, real data, and engineering principles. This paper explains how technical evaluations can support regulatory risk assessments and best practices, making the process more efficient and easier to understand.
Regulatory agencies set clear rules for how companiesshould manage risk. Guidelines such as ICH Q9, ICH Q10,FDA’s Quality Systems Approach, and EMA Annex 15 stressthe importance of using scientific methods and data tomake risk-based decisions. These rules encouragecompanies to use technical data rather than assumptionsor past practices when identifying risks, assessing theirimpact, and implementing risk controls measures tominimize risk levels. While agencies like the FDA, EMA, andMHRA have similar goals, they may have differentrequirements and enforcement methods. Companiesworking in multiple regions need to understand thesedifferences to stay compliant and ensure their riskmanagement strategies align with internationalregulations.
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