AMR Industry Alliance Updates Responsible Manufacturing Standard, Further Aligning with WHO Guidance
Geneva, Switzerland, 13 May 2025 — The AMR Industry Alliance today announced it has updated its Antibiotic Manufacturing Standard, further aligning the framework with the World Health Organization’s 2024 Guidance for Responsible and Sustainable Manufacturing of Antibiotics. The Standard provides clear guidance to manufacturers in the global antibiotic supply chain to ensure that their antibiotics are made responsibly, helping to minimize the risk of AMR in the environment.
The AMR Industry Alliance Standard, originally launched in 2022, is the only independently certifiable standard for responsible antibiotic manufacturing. The updated version reflects the latest science and best practices, and incorporates the WHO’s similar provisions for waste management, active pharmaceutical ingredient (API) discharge limits, and transparency in supplier practices.
“We welcome the WHO’s leadership in setting global expectations for responsible antibiotic production,” said Steve Brooks, Chair, Manufacturing Working Group, AMR Industry Alliance. “We are proud to have created the first and only independently certifiable standard and framework controlling for responsible antimicrobial manufacturing.”
Beginning in 2023, BSI launched a certification program, carrying out independent third-party assessments to verify conformance to the Alliance’s Standard, which is crucial for building transparency and trust in the supply chain. The certificates demonstrate the responsible manufacturing of antibiotics at a given manufacturing site, providing independent confirmation that antibiotic emissions are controlled to levels unlikely to increase the risk of AMR developing in the environment. There are now over 60 antibiotic products independently certified across 15 geographies, to the Alliance standard. The BSI AMR certification will incorporate the revised Standard starting in early 2026.
For more information about the Antibiotic Manufacturing Standard, visit: https://www.amrindustryalliance.org/antibiotic-manufacturing-standard/
About the AMR Industry Alliance
The AMR Industry Alliance is the largest private-sector coalition tackling antimicrobial resistance. Bringing together biotechnology, diagnostics, generics, and research-based pharmaceutical companies, the Alliance drives and reports on progress to curb AMR across four pillars: research and science, access, appropriate use, and responsible manufacturing.