Certification to the Antibiotic Manufacturing Standard will be a clear sign that manufacturers in the global antibiotic supply chain are taking necessary steps to ensure antibiotics are made responsibly, helping to minimize the risk of releasing antibiotic waste emissions into the environment.
This follows the publication of the globally applicable industry standard in June 2022.facilitated by BSI for the AMR Industry Alliance, an organization made up of over 100 companies and associations from across the life-sciences industry with the shared goal of providing sustainable solutions to curb AMR
The new certification, developed by BSI to support the Standard, will offer independent third-party verification that waste streams containing antibiotic active pharmaceutical ingredient (API) and drug products are appropriately controlled during manufacturing by pharmaceutical companies. This certification program will involve initial evaluation against the requirements of the standard and annual surveillance to verify ongoing maintenance of the appropriate controls over time.
After the initial launch, all antibiotic manufacturers globally will be eligible to seek certification by BSI. Companies including Centrient, Pfizer, Roche, Sandoz, Teva, Viatris and Haupt Pharma Latina, Member of the Aenova Group, and others, are already seeking to have independent evidence of their compliance to the Antibiotic Manufacturing Standard for a selection of their antibiotics as first market achievers that participated in a pilot program.
In addition to the partnership between BSI and the AMR Industry Alliance, companies involved in the pilot have offered their support in reviewing the development of the technical assessment process and expressed interest in participating in the certification themselves, as well as strongly encouraging their supply chain partners to do so.
The BSI certification has been designed to encourage antibiotic manufacturers and those in the supply chain to prioritize the sustainable production of medicines, with many pharmaceutical organizations aligning their waste control programs under their broader sustainability program objectives. Additionally, antibiotic waste controls are becoming important criteria in commercial tenders of healthcare systems.
Modern antibiotics, effectively discovered by Alexander Fleming in the 1920s, remain vital in treating bacterial infections and preventing them during key surgical procedures, amongst other purposes. However, AMR threatens their effectiveness – resulting in a serious threat to global population health. According to the UN, “AMR could push 28.3 million people into extreme poverty by 2050 due to high treatment costs and chronic infections.”
Discharge of antibiotics from manufacturing processes into the surrounding environment is one of several factors that may contribute to the development and transmission of AMR in nature, including in humans. According to the World Health Organization (WHO), AMR is one of the top 10 global public health threats, with scientists estimating there were an estimated total 4.95 million deaths associated with bacterial AMR in 2019, including 1.27 million deaths attributable to bacterial AMR in the same year. The UN Environment Programme (UNEP) recently published an in-depth report, concluding that “the environment plays a key role in the development, transmission and spread of AMR.”
Theuns Kotze, Managing Director, Assurance IMETA, said: “BSI is proud to have partnered with the AMR Industry Alliance on developing this ground-breaking standard and now a certification that will promote responsible pharmaceutical manufacturing and help protect the natural environment and slow resistance. Stricter control of waste streams in manufacturing processes, which seeks to limit antibiotic discharge into the environment, has the potential to keep medicine effective, boost patient safety, and support a cleaner ecosystem.
“In taking a critical step forward to address the growing threat from AMR and reduce discharge from the manufacturing process into the environment, we can work collaboratively to accelerate progress to a more sustainable world.”
Joe Muratore, BSI Product Certification Director, added: “Just as we’re told by our doctors not to take antibiotics for non-bacterial infections because it will make the future use of the drugs less effective, or even ineffective, the same is true of controlling waste discharge of antibiotics from the manufacturing in the environment. Doing so will help retain the long-term effectiveness of antibiotics to treat infections.”
“Ensuring antibiotic manufacturing meets best available scientific standards is an important tool in tackling the rise of antimicrobial resistance. The launch of today’s certification program in partnership with BSI, is a further demonstration of the pharmaceutical industry’s commitment to providing a greater level of trust and verification to the antibiotic supply chain,” stated James Anderson, Chairman of the AMR Industry Alliance. “This builds on the work that the AMR Industry Alliance has led over the past five years and we would encourage all antibiotic manufacturers to seek certification as part of the global effort to reduce the risk of AMR developing.”
“Pfizer was delighted to participate in the pilot program for this new certification program to help ensure appropriate control of antimicrobial manufacturing waste, and looks forward to its adoption across the pharmaceutical industry,” said Dermot Dolan, Internal Audit & Supplier Operations EHS Lead at Pfizer. “Responsible manufacturing of antimicrobials is a key pillar of efforts to help curb the global health threat of AMR, and we are committed to continuing our leadership in this area.”
For more information on the AMR standard and certification program, visit: Antimicrobial resistance (AMR) and how standardization is driving change | BSI (bsigroup.com).