Implementing biocide regulations…burden on GMP plants

Transition period for switching biocides ends…implementation to pharmaceutical manufacturing plant emerges as a variable

Switching disinfectants adds more constraints to GMP, including the need for sterility testing and product quality validation

Potential risks associated with vaccine production are being assessed amid discussions about temporary measures

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Folllowing the implementation of the Biocidal Products Approval System has introduced a new variable to sterile environment management in pharmaceutical manufacturing plants.

​As regulations are applied to the disinfectants and sterilizing agents used to maintain sterility in pharmaceutical manufacturing processes, the burden of replacement and validation is emerging as a new challenge in the manufacutring sector.

​According to the pharmaceutical industry on July 14, concerns over potential on-site confusion have been raised as some disinfectants and sterilizing agents used in pharmaceutical manufacturing facilities intersect with the Ministry of Climate, Energy and Environment (MCEE) s Biocidal Products Approval System.

​Strengthened biocide management since the humidifier disinfectant incident

The background of this issue is the Act on Safety Management of Household Chemical Products and Biocides (K-BPR). This framework was introduced to strengthen the safety management of chemical substances and biocidal products following the humidifier disinfectant disaster.

The system addresses the pre-market regulation of biocidal substances and products used to eliminate or inhibit harmful organisms. Under this structure, even existing substances or products must undergo approval or registration processes after a designated grace period to remain in use.

The government granted a transition period until December 31, 2025, for manufacturers and importers, and until June 30, 2026, for distributors. As of July, the grace period has effectively expired, and the regulations are now fully implemented.

The issue lies in the nature of the disinfectants and sterilizing agents used in pharmaceutical manufacturing facilities. While products applied directly to the human body, such as hand sanitizers, fall under the jurisdiction of the Ministry of Food and Drug Safety (MFDS), disinfectants used to maintain sterile manufacturing environments in cleanrooms and controlled areas within pharmaceutical plants can be subject to the MCEE’s biocidal product regulations.

Currently, pharmaceutical processes manage the manufacturing environment in accordance with Good Manufacturing Practice (GMP) standards. In particular, for sterile manufacturing processes such as vaccines and injectables, environmental control is directly linked to product quality; thus, the environment around workspaces and equipment must be maintained at a certain level to prevent microbial contamination during manufacturing.

​The disinfectants used in this process are treated not merely as cleaning supplies, but as an integral part of manufacturing environmental control. Their areas of use, application methods, dosage, rotation cycles, and quality documentation are all managed within the facility's quality management system.

Disinfectant replacemet is not simply a procurement change

​The primary concern for the industry lies in the process of replacing disinfectants or sterilizing agents. If a situation arises where existing disinfectants can no longer be used or must be immediately replaced with approved products, pharmaceutical companies face challenges that go far beyond simply sourcing alternative products.

Under the GMP framework, changing even a single disinfectant requires significant time and resources. Industry insiders point out that the impact of the new disinfectant on work areas and equipment must be thoroughly evaluated and reviewed.

​Furthermore, the industry explains that efficacy testing against microorganisms is mandatory. Validation must be performed to verify whether the new disinfectant delivers the same level of bactericidal effect as the previous product. This process inevitably entails revisions to cleaning and disinfection procedures, environmental monitoring standards, standard operating procedures (SOPs), and quality documentation.

Concerns are also raised that currently approved biocidal products may not fully satisfy the stringent requirements demanded by pharmaceutical GMP. This implies that simply being an approved product does not mean it can be immediately introduced into a sterile manufacturing environment.

​A pharmaceutical industry official explained, "Since biocides are not directly introduced into the bulk vaccine substance but are used to sanitize the manufacturing environment to maintain sterility, they do not affect the ingredients or stability of the vaccine product itself. However, under GMP, changing even a single disinfectant inevitably requires several months or more of time and resources."

​Discussions on temporary relief measures underway…facilities must prepare responses

Consequently, there are worries that forcing an immediate switch to alternative disinfectants without government grace periods could create physical bottlenecks and operational risks for production and release schedules due to the time required for product review and mandatory validation.

However, production disruptions have not materialized at this stage. The industry and relevant government ministries are continuing discussions on practical implementation methods at manufacturing sites, and temporary relief measures are reportedly being considered for disinfectants and sterilizing agents used in biopharmaceutical manufacturing.

​The pharmaceutical industry is also assessing risks with a primary focus on supply stability. Manufacturers are auditing the approval status of their currently used disinfectants, identifying potential alternatives, and assessing the need for change control, while actively consulting with relevant ministries and industry associations.

Experts advise that in the long run, companies must prepare their own response strategies regardless of the discussions surrounding regulatory grace periods. Some companies are reportedly not fully aware of the approval requirements for products used on-site or directly imported, making on-site guidance and raising regulatory awareness key tasks ahead.

​An industry representative commented, "Pharmaceutical manufacturing sites strictly manage sterile conditions in accordance with GMP standards. We are not dismissing the intent of the law. Rather, we need the application standards to be clarified to prevent confusion on-site, taking into account the unique characteristics of the pharmaceutical manufacturing environment."

He added, "For products with critical supply schedules, such as vaccines that must be supplied during specific seasons, even a minor change can case a significant burden on the shop floor. It is crucial for government agencies and the industry to cooperate and coordinate so that the system can be successfully implemented without causing supply disruptions."