Blog
WHO guidance on tackling AMR
Posted on the 22nd November 2024
Victoria Benton, Senior Regulatory Executive, brings G&L’s World Antimicrobial Resistance Awareness Week (WAAW) coverage to a close with an introduction to new guidance released by the World Health Organization (WHO).
This guidance aims to tackle antimicrobial resistance (AMR) by providing standards for managing wastewater and solid waste from antibiotic manufacturing.
The guidance addresses the rising threat of AMR and lays out actionable recommendations to protect human, animal, and environmental health.
AMR remains one of the most urgent global health threats, with the World WHO ranking it among the top ten public health challenges worldwide.
While antibiotics are essential for preventing and treating infections, their presence in environmental waste, especially via manufacturing wastewater, can negatively affect ecosystems and promote AMR.
Research shows that wastewater containing pharmaceuticals, particularly from human and animal waste, is a source of active pharmaceutical ingredients (APIs) in the environment.
Antibiotic manufacturing facilities can contribute to concentrations of these compounds, intensifying AMR development by exposing environmental microorganisms to antibiotics, with the potential to spread worldwide.
This situation threatens the long-term efficacy of antibiotics used for humans, livestock, companion animals, and crops. Change is therefore necessary within the pharmaceutical industry to regulate pollution from wastewater.
To address these risks, the WHO released its first Guidance on Wastewater and Solid Waste Management for Manufacturing of Antibiotics in September 2024.
This guidance, called for by a range of international bodies (including the WHO Executive Board, the G7 health ministers and UNEP) has been developed with a One Health perspective. It addresses the intersections of human, animal, and environmental health, emphasizing a comprehensive approach to AMR risk reduction.
Its primary purpose is to establish an independent, scientifically derived framework that applies specific targets to manage liquid and solid waste from antibiotic manufacturing (excluding other antimicrobials like antiparasitics, antivirals, and antifungals).
The recommendations offered in the guidance are applicable across manufacturing, from APIs to formulation and packaging.
The guidance is intended for eight primary audiences involved in antibiotic waste management. These include environmental and public health regulatory bodies, pharmaceutical regulators, and investors in the pharmaceutical sector. By reaching these stakeholders, WHO aims to foster industry-wide compliance and adoption of AMR-reducing practices.
Within the guidance, manufacturers are instructed to identify and manage environmental risks in close collaboration with various stakeholders, including quality assurance and health and safety teams.
Notably, the WHO’s guideline follows the launch of the BSI Minimized Risk of Antimicrobial Resistance certification in June 2023. This certification allows manufacturers to validate their risk management practices through internal and external audits, supporting transparency and accountability.
The shift towards effective wastewater management represents a significant challenge for antibiotic manufacturers, but the WHO advocates for a phased approach to implementation.
The guidance introduces a two-tier system of “good” and “stringent” targets, allowing gradual progress. Training and capacity-building within companies are essential for enabling the effective adoption of these standards.
By committing to responsible manufacturing practices, companies can not only contribute to controlling the rise of AMR but also enhance their position within the global market.
The WHO recognizes that scientific and operational gaps remain and that further updates to the guidance will be issued to reflect ongoing advancements and practical experiences from industry stakeholders.
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Victoria Benton is a Senior Regulatory Executive a G&L.
