According to the World Health Organization, antimicrobial resistance (AMR) has been declared a top 10 global public health threat and is expected to get worse unless action is taken. Resistance can come from many sources – BSI is working with the pharmaceutical industry to focus on the evolution of responsible manufacturing of antibiotics.

Manufacturing waste from the production of antibiotics can contribute to the development of AMR in the environment unless emissions from waste streams are effectively controlled. It threatens to undermine the basis of modern medicine by rendering the antibiotics used to treat and prevent infections ineffective.

In 2019, AMR bacteria accounted for 1.27 million deaths and contributed to almost another five million deaths during the same year, according to IHME/The Lancet. 

BSI driving action and progress

Standard:

The AMR Industry Alliance engaged BSI to facilitate the development of a private standard by working with the Alliance and multiple industry stakeholders. A comprehensive industry standard was published in June 2022, for assessing the impact of pharmaceuticals in the environment for the Anti-Microbial Resistance topic, called the Antibiotic Manufacturing Standard.

Certification:

The AMR Alliance and BSI have developed an industry certification program, which launched 6 June 2023. BSI will serve as an assessment body role that will enable antibiotic manufacturers to demonstrate that the wastewater dilution and control requirements of the Antibiotic Manufacturing standard have been satisfied.

This independent and impartial certification program is perfectly situated to serve as a mechanism for antibiotic manufacturers to show evolving good practice. While government regulators have a role to play in promoting responsible manufacturing, the industry has shown its willingness to self-regulate by developing this manufacturing standard and independent certification scheme.

If you would like to find out more about our AMR certification scheme, view our on-demand webinar: