WHO issues guideline to curb antibiotic pollution
The World Health Organization (WHO) has finalized its first-ever guidance to limit waste from antibiotic manufacturing facilities in an effort to address antimicrobial resistance (AMR).The guidance includes minor revisions from a draft version issued last December. (RELATED: WHO offers guidance on reducing antimicrobial waste from manufacturing sites, Regulatory Focus 15 January 2024)
In announcing the guidance, WHO said “the emergence and spread of AMR caused by antibiotic pollution could undermine the effectiveness of antibiotics globally, including the medicines produced at the manufacturing sites responsible for the pollution.”
The agency further notes that despite the fact that high levels of antibiotics have been “widely documented” in water bodies downstream of manufacturing sites that “antibiotic pollution from manufacturing is largely unregulated and quality assurance criteria typically do not address environmental emissions.”
The 98-page document establishes a framework for manufacturers to manage these discharges from antibiotic manufacturing facilities. It adopts a common conceptual framework used in WHO water safety guidance documents and covers three core elements, including defining targets for resistance selection and ecological effects based on exposure and risk assessment, establishing risk management processes to reach those targets using the principles of hazard analysis and critical control points, and recommending independent audits to verify targets are being met.
The guidance covers all antibiotics intended for all human or animal use and covers all steps from the manufacturing of active pharmaceutical ingredient and formulations into finished products, including primary packaging. It also establishes human health-based targets for reducing the emergence and spread of antibiotic resistance and includes a system for risk management to meet targets and verification by external audits.
The guidance states that manufacturing facilities should implement risk management plans, including internal audits to ensure targets are met. Such plans may be either stand-alone or incorporated into other risk management exercises, and manufacturers should also engage and make results available to auditors and the public.
WHO said the guidance complements other guidance on the assurance of the quality and safety of pharmaceuticals, such as the WHO Annex 6: “Points to consider for manufacturers and inspectors: environmental aspects of manufacturing for the prevention of antimicrobial resistance.”
The guidance will be presented to the United Nations General Assembly (UNGA) meeting on 26 September 2024.
“Pharmaceutical waste from antibiotic manufacturing can facilitate the emergence of new drug-resistant bacteria, which can spread globally and threaten our health. Controlling pollution from antibiotic production contributes to keeping these life-saving medicines effective for everyone," said Dr Yukiko Nakatani, WHO Assistant Director-General.
WHO guidance
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