Antimicrobial resistance (AMR), has been identified by World Health Organization as a top 10 global public health threat, and is expected to have an increasingly negative impact unless action is taken. A key cause of antimicrobial resistance is manufacturing waste from the production of antibiotics being released into the environment, for example through wastewater.
Our BSI Kitemark for minimized risk of antimicrobial resistance certification program has been developed in partnership with the AMR Industry Alliance, with consultation from financial investors, NGOs, government, regulators and healthcare system procurers who purchase antibiotics from pharmaceutical manufacturers. By achieving Kitemark certification, manufacturers demonstrate that their antibiotics have been manufactured with effective controls in place or reduce AMR. By identifying risk, minimizing antibiotics entering waste streams, and validating data to confirm that their Predicted Effective Concentration (PEC) is below a threshold level as determined in the AMRIA Manufacturing standard. Certification can be awarded to both antibiotic APIs (active pharmaceutical ingredients) and antibiotic finished drug products.
