Glossary
Quality Risk Management (QRM)
What is Quality Risk Management (QRM)?
Quality Risk Management (QRM) is a systematic process for assessing, controlling, communicating, and reviewing risks to the quality of a product across its lifecycle. This approach is utilized primarily in the pharmaceutical and biotechnology industries to ensure that products meet the required quality standards and regulatory compliance. QRM involves identifying potential risks, evaluating their impact and likelihood, implementing control measures to mitigate them, and continuously monitoring the effectiveness of these controls. This process helps to maintain product safety, efficacy, and quality while optimizing resource utilization and decision-making.
What are the key elements of Quality Risk Management (QRM)?
- Risk Assessment: Identifying potential risks to product quality, evaluating the likelihood and severity of these risks, and prioritizing them
- Risk Control: Implementing measures to mitigate or eliminate identified risks, ensuring that risk control measures are effective
- Risk Communication: Sharing information about risks and risk management activities among stakeholders to ensure transparency and informed decision-making
- Risk Review: Continuously monitoring and reviewing risk management activities to ensure ongoing effectiveness and to identify any new risks that may arise
Why is QRM important in pharma?
Quality Risk Management (QRM) is extremely important in the pharmaceutical industry for several key reasons:
- Patient Safety: The primary goal of QRM is to identify, assess, and mitigate risks that could impact patient safety. Pharmaceutical products must be of the highest quality to ensure they are safe and effective for consumers.
- Regulatory Compliance: QRM is a regulatory requirement for pharmaceutical companies. Adhering to guidelines like ICH Q9 demonstrates compliance and builds trust with regulatory authorities.
- Efficient Resource Allocation: Quality Risk Management (QRM) allows companies to focus resources and efforts on the most critical risks, rather than wasting time on low-risk activities. This optimizes operations and reduces waste.
- Continuous Improvement: QRM is an ongoing, iterative process that supports continuous improvement in pharmaceutical processes, systems, and product quality over the entire product lifecycle.
How does QRM ensure regulatory compliance?
Quality Risk Management (QRM) ensures regulatory compliance by identifying and mitigating risks that could impact product quality, complying with regulatory requirements, such as GMP and GCP, documenting and recording risk assessments and controls, providing a clear audit trail for regulatory inspections, promoting a culture of quality within pharmaceutical companies, aligning with regulatory guidance and standards, such as ICH Q9 and EU GMP Annex 20, etc.
