Antibiotic Manufacturing Standard
The Standard marks the formalization of the Alliance’s 2018 Common Antibiotic Manufacturing Framework, which described a risk-based approach to assessing and controlling antibiotic manufacturing waste streams. The AMR Industry Alliance engaged BSI, the business improvement and standards company, to provide expert services in relation to the development of this antibiotic manufacturing standard. BSI facilitated the development of the Standard by working with the Alliance and a number of industry stakeholders.
As such, the Standard requires that the manufacturer of an antibiotic must have an effective environmental management system and that the antibiotic’s Predicted No-Effect Concentrations, or the level at which a substance will not have an adverse effect on its environment, are met. To provide further guidance and quality assurance, the Alliance and BSI will also develop a certification scheme that will enable antibiotic manufacturers to demonstrate, through independent third-party evaluation, that the requirements of the Standard have been satisfied.