December 19, 2024
December 19, 2024
On September 3, 2025, the World Health Organization (WHO) released its first guidance to mitigate antibiotic pollution from manufacturing. This directive, which outlines wastewater and solid waste management practices for antibiotic production, comes in anticipation of a High-Level Meeting on antimicrobial resistance (AMR) set to take place during the UN General Assembly in New York.
AMR develops when bacteria, viruses, fungi, and parasites adapt over time, making treatments ineffective. This resistance is largely fueled by the overuse and misuse of antimicrobials, although many still lack access to these vital medicines globally.
WHO highlighted that the emergence and spread of AMR due to antibiotic pollution could compromise the effectiveness of antibiotics worldwide, including those produced at polluting manufacturing sites. Despite the documented high levels of antibiotic pollution, regulation is minimal, and existing quality assurance measures often overlook environmental emissions.
Consumers also face challenges due to insufficient guidance on properly disposing of unused antibiotics, such as those that have expired or remain after a completed course of treatment.
WHO emphasized that pharmaceutical waste from manufacturing can promote the rise of new drug-resistant bacteria, posing a global health threat. Controlling this pollution is essential for maintaining the efficacy of these critical medicines.
There is a notable lack of available data on the environmental impact of pharmaceutical production. WHO pointed out that calls for guidance have come from various international bodies, including G7 health ministers and the UN Environment Programme (UNEP).
UNEP highlighted that the environment's role in the development, transmission, and spread of AMR demands careful attention as evidence continues to grow. Addressing pollution prevention and control from various sources, including manufacturing sites, healthcare facilities, municipal systems, and agri-food systems, is critical.
The WHO's new guidance was developed with input from a diverse group of international experts, such as regulators, inspectors, academics, and representatives from other sectors. It sets targets to protect human health and aquatic life from risks posed by antibiotics used for human, animal, or plant treatment. The entire manufacturing process, from the production of active pharmaceutical ingredients (APIs) to the final formulation and primary packaging, is included.
The guidance provides a scientific foundation for regulators, procurers, inspectors, and industry stakeholders to incorporate robust antibiotic pollution controls into their standards. A significant emphasis on transparency aims to empower buyers, investors, and the public to consider manufacturers' efforts in pollution management when making decisions.
TAGS: Quality & Compliance WHO
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