The British Standards Institution (BSI) announced today that drugmakers Sandoz and Teva have become the first companies to be certified as meeting an international standard for responsible antibiotic manufacturing.
The Minimized Risk of Antimicrobial Resistance (AMR) certification, developed by BSI in collaboration with the AMR Industry Alliance, provides third-party independent verification that the concentration of antibiotic waste released into the environments by companies that manufacture antibiotics and their raw ingredients is below a threshold that could promote AMR in the environment. The threshold was established in a globally applicable responsible antibiotic manufacturing standard published in 2022.
Concerns about AMR in the environment
The certification attests to the fact that the companies are taking the necessary steps to control waste streams containing antibiotic active pharmaceutical ingredients. The Sandoz manufacturing site in Kundl, Austria, was the first to complete the assessment process. Annual surveillance will be conducted to ensure the standard is being maintained.
Controlling waste discharge of antibiotics from manufacturing can help retain the long-term effectiveness of antibiotics to treat infections, keeping medicine effective, boosting patient safety, and supporting a cleaner ecosystem.
BSI and the AMR Industry Alliance developed the certification to address concerns that discharge of antibiotics from manufacturing sites is contributing to the development and transmission of drug-resistant pathogens in the environment.
“Controlling waste discharge of antibiotics from manufacturing can help retain the long-term effectiveness of antibiotics to treat infections, keeping medicine effective, boosting patient safety, and supporting a cleaner ecosystem,” Courtney Soulsby, global director of healthcare at BSI, said in a press release. “It’s fantastic to see Sandoz and TEVA achieve certification, making clear their commitment to ensuring antibiotic manufacturing meets the best available scientific and environmental standards.”