All productive activities involve some type of risk. However, in sectors that deal with health, such as the pharmaceutical industry, the responsibility for ensuring people’s safety increases even more. After all, we are talking about something primordial.

Therefore, as a result of this importance, there is risk management. It is a tool that allows companies to assess the dangers involved in their processes and make decisions to validate the safety of medicines. Want to know more about how this process works? So, see below the most important points of this risk:

Learn how risk management developed in Brazil

The first experiences with risk analysis tools in the pharmaceutical industry took place in Brazil in the 1990s. At that time, the sector needed to adapt tools aimed at the food market in order to predict problems that could occur in its processes.

In 2003, the World Health Organization (WHO) adapted risk management to the process of developing and manufacturing products for human and veterinary health.

Risk analysis in the pharmaceutical sector became a requirement as of RDC nº 17/2010, which deals with Good Manufacturing Practices (GMP) for medicines. Another resolution, Anvisa’s RDC nº 73/2016, which deals with post-registration changes to medicines, also included the need for risk analysis.

Therefore, with these standards, companies in the pharmaceutical sector had to change. They now have to present a risk plan to obtain or renew licenses and health registrations.

Understand what risk management is

Risk management is a process of selecting measures to prevent and control problems based on an assessment of risks relevant to human, animal and environmental health. It aims to improve decision making; reduce subjectivity; establish transparent and predictable methods; provide confidence to regulatory bodies.

Risk management must include systematic processes designed to coordinate, facilitate and improve decision-making based on scientific criteria. It involves a broad concept, supported by three aspects.

The first of these is the protection of the product against the possibility of cross-contamination; contamination by residues of cleaning and/or sanitizing agents; microbial contamination; exposure to temperatures and/or humidity that are harmful to the stability of the product. Protection against possible contamination due to operators’ lack of care must be observed at any manufacturing stage.

Another important aspect is the protection of operators. It must be against possible risks caused by contact or ingestion of the components of the formulations or by contaminants transmitted by the air system; and also the risks arising from temperature and humidity conditions that cause discomfort to operators.

Finally, management ensures the protection of the environment against harmful effects caused by solid waste, liquids or vapors that are deposited in effluents, delivered to companies contracted for their destination, or emitted into the air.

Learn how to implement risk management

The implementation of decisions defined in risk management can be achieved using management tools or through internal procedures such as Good Manufacturing Practices.

Among the main tools used in risk analysis, two stand out: Failure Mode and Effects Analysis (FMEA − acronym in English for Failure Mode Effects Analysis); and Hazard Analysis and Critical Control Points (HACCP – Hazard Analysis and Critical Control Points). FMEA is used to analyze risk grading (severity, occurrence and detection). HACCP is used to identify the risk.

The ICH-Q9 guide, produced in 2005 by ICH, an international group that brings together regulatory authorities and pharmaceutical industry associations, systematized risk assessment at all stages and manufacturing activities and made this process more scientific.

See what risks are involved in manufacturing medicines

A risk can be defined as the combination of the probability of failures occurring, the detection levels implemented by the company and the severity of this failure (Risk Degree – NPR). Any quality deviation that may occur in the company must be mitigated, even if it has never occurred.

The risk to which a medicine will be subjected during the manufacturing process must be predicted considering three main factors: health risks, known risks and unknown risks.

All stages of the medicine production chain must have their risks mitigated. This goes from receiving the inputs, manufacturing and analyzing the medicine, to its dispatch. Ideally, the risk assessment should be carried out proactively, without the failure having occurred.

Learn the difference between risk analysis and risk management

Risk analysis is a systematic process of applying quality management tools that aims to identify, control, disclose and review the procedures and practices used in the manufacture of medicines.

However, risk analysis should not be confused with risk management. This involves a much broader process, in order to mitigate risks, identify possible causes and promote preventive actions and controls so that failures do not happen. The application of risk analyzes in activities such as validation studies, for example, is just the beginning of this process.

It is also worth noting that risk analysis and management are not exclusive tasks for the company’s management, on the contrary. All sectors must be involved, from receiving the raw material to leaving the final product.

For an effective assessment of the main routines, process limits and critical points of manufacturing control, a qualified team of specialists must be formed who are well aware of the risks inherent to the activities carried out by the company.

These specialists must have knowledge in areas such as pharmaceutical sciences, pharmacology, chemistry, laboratory analysis, biology, microbiology, materials engineering, air systems, automation, bioengineering, robotics and mechanics, among others.

As we have seen, risk management is a systematic process. It is based on scientific parameters and carried out by a multidisciplinary and specialized team, in order to mitigate risks, promote preventive actions and controls so that failures do not occur in the production of medicines.

Do you understand how risk management works? Do you want to know more about the standards that govern the sector? Then see this article about Anvisa and MAPA standards.