[Reporter’s View] When intent doesn’t meet reality

While covering the issue of disinfectants used at pharmaceutical plants, the first thing that came to mind was the distance between regulatory necessity and real-world application.

In the wake of South Korea’s deadly humidifier disinfectant scandal, few would dispute the need for tighter controls on chemicals and biocidal products. The intent of the system, which is to manage potentially hazardous substances in advance and establish clear standards for their use, is necessary.

However, just because a system is designed with the right intentions does not mean it translates seamlessly into the field. Particularly in spaces like pharmaceutical manufacturing, where rigorous quality control systems are already in place, even minor changes in standards can lead to compounding procedural and validation burdens.

On the surface, the issue appears straightforward. A biocidal product management system has been introduced, and pharmaceutical plants simply need to use disinfectants and sterilizing agents that meet the applicable standards. Yet, at pharmaceutical manufacturing sites, switching even a single disinfectant goes far beyond a simple change in procurement.

This issue is unrelated to the ingredients or safety of the manufactured vaccines themselves, as the biocidal substances are not entering the vaccine drug substance or being mixed into finished products. The issue involves products used to disinfect manufacturing environments, including work areas, cleanrooms, and controlled areas at pharmaceutical plants.

At pharmaceutical plants, disinfectants used to maintain aseptic conditions in work areas and cleanrooms are managed under Good Manufacturing Practice (GMP) standards. In the case of products such as vaccines and injectables, where aseptic control is particularly important, the manufacturing environment itself forms part of quality control.

Therefore, every single disinfectant is managed according to the area and method of use, the amount applied, the replacement cycle, and relevant quality documentation. Before switching to a new product, manufacturers must verify that it provides the same disinfecting efficacy as the existing one and assess whether it may cause corrosion or reactivity issues with equipment or materials. Where necessary, cleaning and disinfection procedures, environmental monitoring standards, and standard operating procedures may also need to be revised.

Nor can a product be used immediately at a GMP manufacturing site simply because it has received regulatory approval. A product that meets environmental safety standards is not necessarily the same as one suitable for maintaining an aseptic environment at a pharmaceutical plant.

This is where gaps between the regulatory systems of different ministries become apparent. Products applied directly to the human body are regulated by the Ministry of Food and Drug Safety, while disinfectants used in manufacturing environments fall under the Ministry of Climate, Energy and Environment regulations. While the division of roles seems reasonable, the two domains do not neatly divide within the space of a pharmaceutical manufacturing site.

From the Ministry of Climate, Energy and Environment’s perspective, such a product would be a biocidal product used at a workplace. From the Ministry of Food and Drug Safety’s perspective, however, it is a GMP-controlled element used to maintain the pharmaceutical manufacturing environment. The same product is viewed through two conflicting regulatory frameworks.

This does not mean that safety regulations should be eased in any way, as the lessons of the humidifier disinfectant tragedy are clear. Rather, the application of safety regulations must be refined so that they do not give rise to new supply risks.

For products such as influenza vaccines, which must be supplied during a specific period, even a minor change can become a burden. Replacing and validating a disinfectant takes time, and this may also create risks for production and release schedules.

What is needed now is not a dispute over responsibility. The government should preserve the purpose of the regulations while establishing implementation standards that reflect the unique GMP requirements of pharmaceutical manufacturing sites. The industry, for its part, should not merely ask for grace periods, but should review the products in use and put systems in place to respond to the regulations.

Regulations are becoming more stringent, yet sites that fall across ministerial boundaries are often left in regulatory blind spots. The issue of disinfectants used at pharmaceutical plants is one such example.

It is time for the system to acknowledge the realities of the field and why changing a single disinfectant requires months of validation and paperwork.