What is the best way to handle GMP risk management issues during production or distribution?

1 Risk assessment

The first step in GMP risk management is to conduct a risk assessment, which is a systematic and structured method to identify and prioritize the sources and consequences of risks. A risk assessment should consider the product characteristics, the process parameters, the equipment and facilities, the personnel and training, the materials and suppliers, the environmental conditions, the regulatory requirements and the customer expectations. A risk assessment should use appropriate tools and techniques, such as failure mode and effects analysis (FMEA), hazard analysis and critical control points (HACCP), fault tree analysis (FTA) or risk ranking and filtering (RRF).

2 Risk control

The second step in GMP risk management is to implement risk control measures, which are actions or strategies to reduce, eliminate or mitigate the risks identified in the risk assessment. Risk control measures should be based on the principle of ALARP (as low as reasonably practicable), which means that the residual risk should be acceptable in relation to the benefits and costs of the risk reduction. Risk control measures may include design changes, process improvements, preventive maintenance, quality checks, training, documentation, contingency plans or emergency procedures.

3 Risk communication

The third step in GMP risk management is to communicate the risk information, which is the process of sharing and exchanging the results and outcomes of the risk assessment and risk control activities among the relevant stakeholders. Risk communication should be transparent, consistent, timely and accurate, and should involve the participation and feedback of the people who are responsible for or affected by the risks. Risk communication may include reports, presentations, meetings, audits, inspections, reviews or consultations.

4 Risk review

The fourth step in GMP risk management is to conduct a risk review, which is the process of monitoring and evaluating the effectiveness and performance of the risk management system. A risk review should verify that the risk control measures are implemented correctly and are achieving the desired results, and should identify any new or emerging risks that may require further action. A risk review should use appropriate indicators and metrics, such as key performance indicators (KPIs), quality attributes, deviations, complaints, incidents or corrective and preventive actions (CAPAs).

5 Risk documentation

The fifth step in GMP risk management is to document the risk information, which is the process of recording and maintaining the evidence and records of the risk management activities. Risk documentation should provide a clear and traceable history of the risk management process, from the identification and assessment of risks to the implementation and review of risk control measures. Risk documentation should follow the data integrity principles of ALCOA (attributable, legible, contemporaneous, original and accurate), and should comply with the relevant standards and regulations.

6 Risk culture

The sixth step in GMP risk management is to foster a risk culture, which is the set of values, beliefs, attitudes and behaviors that support and encourage the effective implementation of risk management practices. A risk culture should promote a proactive, preventive and continuous approach to risk management, and should empower and motivate the people who are involved in or affected by the risks. A risk culture should be aligned with the organizational vision, mission and goals, and should be communicated and reinforced through leadership, training, recognition and feedback.

7 Here’s what else to consider

This is a space to share examples, stories, or insights that don’t fit into any of the previous sections. What else would you like to add?