AMR Industry Alliance Launches Antibiotic Manufacturing Standard to Help Mitigate the Impacts of Antimicrobial Resistance

Standard provides guidance, calls on manufacturers to improve waste management programs.

Geneva – June 14, 2022 The AMR Industry Alliance, the largest life-sciences coalition set up to provide sustainable solutions to curb antimicrobial resistance (AMR), today announced another groundbreaking step in driving responsible antibiotic manufacturing through the publication of its Antibiotic Manufacturing Standard: Minimizing risk of  developing antibiotic resistance and aquatic ecotoxicity in the environment resulting from the manufacturing of human antibiotics. The Standard, facilitated by BSI Standards Limited (BSI), provides clear guidance to manufacturers in the global antibiotic supply chain to ensure that their antibiotics are made responsibly, helping to minimize the risk of AMR in the environment.

“Antimicrobial resistance is one of the biggest public health challenges of our time. Our Alliance’s Standard launches the next chapter of responsible manufacturing throughout the global antibiotic value chain,” said Thomas Cueni, Chair of the AMR Industry Alliance and Director General of the International Federation of Pharmaceutical Manufacturers and Associations. “Alliance members have been leading the way in encouraging responsible antibiotic manufacturing practices, and the new Standard serves as a call to action for others to join us in this fight.”

Antibiotics are essential innovations that have revolutionized modern healthcare, but the rise of antimicrobial resistance is threatening their effectiveness. Since its establishment, the AMR Industry Alliance has been developing solutions to drive the industry to minimize any contribution to antimicrobial resistance that may arise as a result of the processes used to make these important medicines.

Today, AMR is a top 10 global public health threat according to the WHO and it’s only expected to get worse. Unchecked, it threatens to undermine the basis of modern medicine by rendering the antibiotics used to treat and prevent infections ineffective, making mainstream medical advances like chemotherapy, hip replacements, caesarian sections, and root canals, risky and even deadly. In 2019 alone, antimicrobial resistant bacteria accounted for 1.27 million deaths and contributed to another nearly 5 million deaths during the same year, according to IHME/The Lancet.

“The AMR Industry Alliance has taken a bold step towards combatting the spread of AMR in the environment,” said Courtney Soulsby, Global Director of Healthcare and Life Sciences with BSI. “The AMR Industry Alliance’s standard, which is now live, and the subsequent certification scheme, which will be launched next spring by the Alliance and BSI, will build much needed global awareness, encourage decisive actions, and provide an external, independent assurance mechanism, leading to a new model of transparency for the industry.”

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.

To read the Standard, click here.


date 13/06/2022