New WHO guidance to support manufacturers to reduce AMR risk

The recommendations offered in the guidance is applicable across different areas of manufacturing, from active pharmaceutical ingredients (APIs), through to formulation and packaging.

The World Health Organization (WHO) has published its first guidance on antibiotic pollution from manufacturing, to help the industry mitigate the global risk of antimicrobial resistance (AMR). It discusses the management of wastewater and solid waste for the manufacture of antibiotics. 

“Pharmaceutical waste from antibiotic manufacturing can facilitate the emergence of new drug-resistant bacteria… Controlling pollution from antibiotic production contributes to keeping these life-saving medicines effective for everyone,” explained Dr Yukiko Nakatani, WHO Assistant Director-General for AMR ad interim.

“By investing in responsible manufacturing, companies can help curb rising drug resistance while positioning themselves favourably in the market,” stated Director of Operations and Research Marijn Verhoef, Access to Medicine Foundation, in response to publication of the organisation’s report on AMR and responsible manufacturing.

WHO’s guidance “provides an independent and impartial scientific basis for regulators, procurers, inspectors, and industry themselves to include robust antibiotic pollution control in their standards,” stated Dr Maria Neira, Director, Department of Environment, Climate Change and Health, WHO. “Critically, the strong focus on transparency will equip buyers, investors and the general public to make decisions that account for manufacturers’ efforts to control antibiotic pollution.” 

Minimising the risk of antimicrobial resistance

The WHO’s new report follows launch of the BSI Minimized Risk of Antimicrobial Resistance (AMR) certification for antibiotic manufacturing in June 2023. By certifying, companies (such as Sandoz and Teva), can help to “mitigate the risk of the development and spread of AMR in the environment,” shared Courtney Soulsby, Global Director of Healthcare Sustainability at BSI and Steve Brooks, Manufacturing Working Group Chair at the AMR Industry Alliance.

Last month, the British Standards Institute (BSI) reported that for antibiotic suppliers applying for the new NHS Antimicrobial Product subscription model, the manufacturers will need certify for the BSI Kitemark for Minimized Risk of Antimicrobial Resistance (AMR). Complying with the standard verifies that these companies have “appropriately controlled waste discharge into surrounding environment”.

Source