Responsible Manufacturing
AMR Industry Alliance Standard and Antibiotic Discharge Targets
In May 2025, the AMR Industry Alliance updated its Antibiotic Manufacturing Standard to better align with the World Health Organization’s 2024 Guidance, advancing efforts to reduce antimicrobial resistance (AMR) in the environment. The update reflects the latest science and includes stricter waste management, API discharge limits, and greater supply chain transparency.
Originally launched in 2022, the Alliance’s standard is the only independently certifiable standard for responsible antibiotic production. Since 2023, BSI has certified over 60 antibiotic products across 15 geographies, with the revised standard set to roll into certification by early 2026. This standard built upon the framework created in 2018 to promote responsible antibiotic manufacturing.
The AMR Industry Alliance also led research (results published in Society of Environmental Toxicity and Chemistry in early 2022) to further establish a default predicted no-effect concentration (PNECs) for those antibiotics not currently on the list of 125 antibiotics studied by the Alliance team. This publication is an important step in the continuing journey as companies work toward achieving these target values. The default value of 0.05 µg/L for antibiotics is based on statistical evaluation and is a conservative calculation. This new study provides data-driven guidance to manufacturers of those antibiotics not on the PNEC list on minimizing antibiotic resistance and environmental toxicity. The PNEC tables are continuously updated, with the most recent update accompanying the launch of the revised standard in 2025.
The AMR Industry Alliance believes working toward achieving these antibiotic discharge concentration targets will be both protective of ecological resources and also lower the potential for the evolution and selection of AMR in the environment. It is important to note that these values are recommended based on currently available information, thus, may change as new reliable and relevant information generated to recognized protocols comes to light.
An effective way to manage antibiotic discharge from all sources requires a multi-stakeholder collaboration. We are aligned in our intent to collaborate with relevant stakeholders to bring our industry knowledge to finding a sustainable solution. The Alliance companies will continue to take action and share their experiences to reduce environmental impact from the production of antibiotics. Continued engagement in scientific discussion with all stakeholders with the aims of expanding the knowledge-base, developing and improving ways to assess risks, and optimizing strategies to deal with AMR, without compromising patient access to necessary medicines, is fundamental to continuing to develops ways to mitigate against AMR.
BSI Kitemarktm
Organizations aiming to demonstrate adherence to the AMR Industry Alliance’s Manufacturing Standard can pursue certification to the BSI Kitemark tm for Minimized Risk of AMR. This certification highlights a commitment to reducing antimicrobial resistance and promoting responsible antibiotic manufacturing. Additionally, it ensures compliance with NHS subscription model AMR tender requirements, Nordic countries’ antibiotic tenders, and other healthcare procurement standards.
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