In the complexity of the production processes of the life sciences sector, risks are inevitable. In-depth understanding of these processes is critical to identifying and mitigating risks. Risk management is not only a best practice, but a regulatory requirement in critical sectors such as pharmaceuticals, cosmetics… under the surveillance of agencies such as ANVISA.
Guide No. 62/2023, a July 2023 publication, serves as a detailed manual for pharmaceutical companies to navigate the complex process of identifying, minimizing, and eliminating risks that affect the integrity and quality of products. Inspired by the ICH’s Q9(R1) guide, this document is a roadmap for effective risk management.
To better understand how risk management can add quality to the product, it is first necessary to understand some basic concepts.
- Hazard: A potential source of harm, which can be physical, chemical, or biological.
- Risk: The likelihood of a damage occurring and the severity of the impact that this damage may cause.
- Inherent Risk: The level of risk prior to the application of any control measures.
- Residual Risk: The level of risk that persists after mitigation measures have been implemented.
Risk identification is a complex process that requires an objective and structured approach. Subjectivity can be minimized with the use of analytical tools and brainstorming sessions to map all potential risks, which will later be evaluated in the risk matrix, in this article we talk more specifically about some well-known methodologies.
Risk management is a continuous cycle of evaluation, control, communication and review, ensuring that product quality is maintained in all phases of its life cycle, in RDCs of good pharmaceutical manufacturing practices for example, the need to have risk management for each decision to be made within the process, expresses the importance of this action for Anvisa and companies.
- Assessment: Detailed analysis of hazards and risks.
- Classification: Determine criteria for classifying risk according to its level of criticality.
- Control: Development of mitigation strategies and definition of tolerance limits for each risk.
- Communication: An ongoing process that involves the dissemination of information about risks and decisions made.
- Review: Monitoring and adjusting risk management strategies to ensure continued effectiveness.
To understand the guide, you can consider:
2. Principles of Quality Risk Management: includes risk assessment based on scientific knowledge and the adequacy of risk management effort to the level of risk.
3. Overall Quality Risk Management Process: Details the steps to manage risks, including risk assessment, control, communication, and review.
4. Risk Management Methodology: discusses formalities in the process, risk-based decision-making, and ways to manage subjectivity.
5. Integration of Risk Management into Operations: addresses how risk management should be incorporated into industrial and regulatory operations to improve decision-making and product quality.
In addition to the appendices, where it is possible to find some methodologies for the application of risk analysis, statistical tools to support and classification and filtering of risks.
The success of risk management depends on collaboration between all areas of the company. A multidisciplinary team with decision-making authority is essential to implement and oversee the risk management process.
At kivalita, we have a methodology that employs risk management in the strategy not only of quality, but in the business strategy, learn how we can help your company and the quality sector achieve the greatest goals.