As indispensable component of ensuring product quality, patient safety, and regulatory compliance, QRM involves a systematic approach to identifying, assessing, controlling, and monitoring risks throughout the entire lifecycle of pharmaceutical products. Risk control measures are then developed and implemented to mitigate or eliminate identified risks. This phase involves strategic decision-making on process improvements, equipment modifications, and other preventive measures. Effective communication of risks and management strategies across all levels of the organization is paramount, fostering a culture of quality and safety. The QRM process is iterative, with regular reviews conducted to ensure ongoing effectiveness and relevance. Continuous monitoring of risk controls and periodic reassessment of identified risks enable adaptation to changes in technology, regulatory requirements, and emerging challenges. A robust documentation system is maintained to provide evidence of compliance with regulatory standards and serve as a historical record of risk management activities. The importance of training and competency of personnel involved in the QRM process is emphasized, ensuring that employees are equipped with the necessary knowledge and skills to contribute to a culture of risk awareness. Integration with existing Quality Management Systems (QMS) is crucial for the success of the QRM process, aligning risk management practices with overall quality objectives. QRM process is characterized as a dynamic and integral component of pharmaceutical operations, contributing to a proactive quality culture. A well-implemented QRM process not only ensures regulatory compliance but also enhances operational efficiency, reduces costs associated with recalls and rework, and positions pharmaceutical companies for sustained success in a complex and evolving industry.