The World Health Organization (WHO) identifies antimicrobial resistance (AMR) as a top 10 global health threat, undermining antibiotics' effectiveness. Through a One Health approach, BSI AMR Kitemark certification addresses AMR in the environment, particularly from antibiotic manufacturing waste.
Pharmaceutical manufacturers face the challenge of controlling waste to maintain safe concentrations of discharge into the environment. BSI AMR Kitemark certification validates compliance with the AMR Industry Alliance’s Antibiotic Manufacturing standard, ensuring antibiotic residue emissions from waste streams are controlled during manufacturing and meet Predicted No Effect Concentration (PNEC) thresholds. Certification applies to all antibiotic manufacturers and provides assurance to stakeholders such as healthcare system procurers, investors, and customers.
Leading antibiotic manufacturers have adopted BSI AMR Kitemark certification for its numerous benefits. The programme is integrated into:
- The NHS antibiotic subscription model and other healthcare procurement requirements.
- The UK national action plan for AMR.
- The Pharmaceutical Supply Chain Initiative (PSCI) audit requirements.
