Sandoz and TEVA have become the first organisations to be certified as meeting an international standard on the Minimized Risk of Antimicrobial Resistance (AMR), demonstrating that they are taking necessary steps to ensure antibiotics are made responsibly, helping to minimise the risk of aquatic toxicity in the environment and the spread of AMR.
The new global Minimized Risk of Antimicrobial Resistance (AMR) certification was developed by BSI, the business improvement and standards company, to confirm the responsible manufacturing of antibiotics in the global supply chain.
Following the certification programme’s launch in June, a range of antibiotic products have now successfully completed the certification process within each of the organizations.
The BSI Kitemark for minimised risk of antimicrobial resistance provides independent third-party verification of the steps being taken to ensure that waste streams containing antibiotic active pharmaceutical ingredient (API) and drug products are appropriately controlled during manufacturing.
It involves an initial evaluation against the requirements of a designated standard and will be maintained by annual surveillance to verify ongoing maintenance of the appropriate controls. Like all BSI certification programmes, it is rigorous and challenging for organizations to achieve.
Courtney Soulsby, BSI Global Director, Healthcare Sustainability, said: “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."
"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."
"Taking this critical step forward to address the growing threat from AMR and reduce discharge into the environment can help us accelerate progress towards a sustainable world.”
Discharge of antibiotics from manufacturing processes into the surrounding environment is one of several factors that may contribute to the development and transmission of AMR in nature, including in humans.
According to the World Health Organization (WHO), AMR is one of the top 10 global public health threats, while the UN Environment Programme (UNEP) has concluded that “the environment plays a key role in the development, transmission and spread of AMR.”
Boumediene Soufi, Head of Sandoz AMR Program, said: “This first-of-a-kind certification demonstrates that Sandoz, the global leader in generic antibiotic medicines, is taking the necessary steps to ensure responsible manufacturing of these critical medicines – a key pillar of the global AMR response strategy.”
Amalia Adler-Waxman, SVP, Global Head, ESG, Teva, said: “At Teva, we are proud to partner with the AMR Industry Alliance and BSI to support responsible manufacturing across the pharmaceutical supply chain — to help ensure a healthy future for people and the planet.”
