The pharmaceutical industry constantly faces challenges and risks, from the development of new medicines to the large-scale production of batches and their distribution to the market. It is crucial for ensuring patient safety and compliance with regulations that these risks are noticed and addressed in a structured and efficient way.
In an increasingly demanding and regulated scenario, companies in the sector must understand how to identify, assess, and mitigate risks to guarantee the safety and effectiveness of the medicines produced. This is where risk management comes in. Risk management is a tool that allows companies to assess the risks associated with their processes and products and make decisions to ensure the safety of medicines.
What is risk management?
For a long time, quality was assessed only from the point of view of products and services, that is, just to verify the quality of the end product. However, it is important to recognize that products and processes are interconnected, as the quality of the process can directly affect the quality level of the end product. Therefore, risk management is integrated into the quality management system as a way to prevent adverse situations during the production of pharmaceutical products.
Thus, risk management can be described as the process of identifying, evaluating, and prioritizing risks and then implementing preventive and corrective actions to minimize these risks. Risk management is, consequently, a comprehensive and multidisciplinary activity that aims to reduce risks, identify potential causes, and implement preventive measures and controls to avoid the incidence of failures and their recurrence.
A comprehensive risk management plan should include:
- Conducting a thorough assessment of the potential risks associated with the production, storage, and distribution of medicines.
- Developing a risk management plan to mitigate and manage these potential risks.
- Implementing preventive and corrective actions, as necessary, to mitigate these risks.
- Continuously monitoring risks and adjusting risk management plans as necessary.
- Establishing clear and regular communication of potential risks with everyone involved in the medicine supply chain process.
What are the benefits of risk management in the pharmaceutical industry?
As we have seen, risk management activities are much more than just paperwork or bureaucratic procedures to satisfy regulators. Therefore, these are some of the most important objectives and benefits of this process:
- Improve decision making if quality problems arise;
- Identify potential failures before deviations and non-conformities occur;
- Evaluate the effectiveness of actions;
- Assess quality trends and process deviations;
- Provide regulators with information about process safety and a company’s ability to respond to potential risks and beneficially influence the scope and level of direct regulatory oversight;
- Describe the company’s quality and safety levels;
- Propose continuous improvements;
- Reduce the number of quality deviations.
Check FDA guidance for industry here.
How to implement risk management?
Effective risk management should include systematic processes designed to coordinate, streamline, and improve decision making related to risks. Hence, the use of specialized software can facilitate and speed up this process, minimizing negative impacts and maximizing positive results.
Taking care of the safety and quality of medicines is essential in the pharmaceutical sector, and our software was developed to simplify and improve your risk management system.
With SoftExpert Suite you will have total control of the risks in your pharmaceutical company. With an easy-to-use and intuitive interface, our solution enables a comprehensive view of all processes and risks associated with the production and distribution of pharmaceutical products.
Our platform offers several features, including:
- Risk assessment: allows identifying, analyzing, and evaluating the risks associated with the processes involved in the production of medicines.
- Incident recording and analysis: allows recording all incidents and adverse events that occur in the pharmaceutical company, enabling a detailed analysis to identify the causes and take preventive measures.
- Root cause analysis: assists in identifying the most prominent causes of problems and incidents, enabling the implementation of effective corrective actions.
- Management of corrective and preventive actions: assists in defining corrective and preventive actions to mitigate identified risks, as well as monitoring the status of the implementation of these actions.
- Monitoring action plans: allows tracking corrective and preventive actions implemented, ensuring that they are performed according to planning and that the results are monitored.
- Change management: helps in managing all changes related to processes, procedures, and products, ensuring that they are compliant and controlled.
- Document management: streamlines management of all documents related to risk management, such as policies, procedures, work instructions, among others.
- Reports and analysis: allows the creation and visualization of performance reports and risk analysis, providing useful information for making strategic decisions.
- Monitoring risk indicators: the software helps in monitoring and analyzing risk indicators, leading to the identification of trends, and acting quickly to avoid problems.
- Training and awareness: the software makes the training process easier and raises awareness among employees about the risks that exist in the pharmaceutical industry, contributing to a culture based on safety.
- Regulatory compliance: assists in meeting pharmaceutical industry regulatory requirements, such as Good Manufacturing Practices (GMP) and other quality standards.
- Integration with other systems: enables integration with other systems used in the pharmaceutical industry.
Don’t risk the reputation of your pharmaceutical company! Invest in our solution and have the peace of mind of producing medicines with quality, safety, effectiveness, and in compliance with all regulations.
