The production of medicines involves various toxicological risks that must be managed appropriately

The production of medicines is an essential industry for public health, but it involves various toxicological risks that must be managed appropriately to protect workers, consumers and the environment.

These risks can arise at various stages of the manufacturing process, from the handling of raw materials to the storage and distribution of the final product.

Handling raw materials

Raw materials used in the production of medicines may include highly reactive and toxic chemical compounds. Workers exposed to these substances may suffer acute and chronic adverse effects, such as skin and eye irritation, respiratory problems or systemic diseases.

To mitigate these toxicological risks, it is essential to implement personal protection measures, such as the use of gloves, masks and protective clothing, as well as ensuring adequate ventilation in work areas.

Synthesis and production process

During the chemical synthesis of active ingredients, various reagents and catalysts are used that can be hazardous. In addition, chemical reactions can generate toxic by-products or hazardous waste.

Exposure to these chemicals can occur through inhalation or skin contact. Implementing engineering controls, such as localized air containment and extraction systems, along with rigorous standard operating procedures, is the basis for minimizing these risks.

Formulation

At the formulation and development stage, where active ingredients are mixed with excipients to create the final product, there may be risks of exposure to fine dusts and aerosols. Excipients, although generally inert, may also present toxicological risks in certain circumstances.

It is important to use closed systems and appropriate handling techniques to minimize the dispersion of these materials in the work environment.

Quality control and testing

Quality control involves handling samples of laboratory products and reagents, which may be toxic. Laboratory technicians must be well trained in the safe handling of these materials and in the correct disposal of waste.

The use of personal protective equipment (PPE) and the application of good laboratory practices are essential to prevent accidental exposure.

In addition, toxicology testing are critical in the pharmaceutical industry given the increasing attention to the detection of impurities in active ingredients. Therefore, rigorous toxicological evaluation is necessary throughout the life cycle of medicines.

Storage and transport

The storage and transport of raw materials, intermediate products and finished products also present toxicological risks. Chemical substances must be stored under suitable conditions to prevent degradation and the accidental release of toxic compounds. During transport, it is vital to ensure that containers are properly labelled and sealed, and that relevant safety regulations are followed.

Waste and environmental management

The production of medicines generates waste that can be toxic and harmful to the environment if not managed properly. This includes solid, liquid and gaseous waste containing hazardous chemicals.

It is essential to implement waste management programs that include the segregation, treatment and safe disposal of waste. In addition, production facilities must have emission control systems to reduce the release of pollutants into the air and water.

Regulations and compliance

The pharmaceutical industry is highly regulated, and compliance with occupational health and safety regulations is critical to mitigating toxicological risks.

Regulatory agencies, such as the Food and Drug Administration (FDA) in the United States and the European Medicines Agency (EMA) in Europe, set rigorous standards for the safe production of medicines. Regular audits and inspections are key tools to ensure that companies comply with these regulations.

Training to avoid toxicological risks

Finally, ongoing training and education of workers is vital to the effective management of toxicological risks. Employees must be trained on the specific hazards of the chemicals they work with, as well as on emergency procedures and safety practices.