A risk-based approach in pharmaceutical manufacturing is a systematic method that involves assessing, prioritising, and managing risks according to their likelihood, severity, and potential impact on patient safety and product quality. This approach is applied across various areas, including quality management, compliance, and decision-making, to efficiently allocate resources, focus efforts, and mitigate risks effectively. By identifying and addressing high-priority risks first, organisations are able to optimise their risk management strategies, enhancing outcomes and achieving superior results. This ensures not only the safety and quality of pharmaceutical products but also minimises resource wastage and the implementation of unnecessary controls, thereby safeguarding both patient well-being and organisational efficiency.
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