NEW CERTIFICATION AIMS TO MITIGATE ANTIMICROBIAL RESISTANCE RISK IN ANTIBIOTIC MANUFACTURING
Certification launched to demonstrate the responsible manufacturing of antibiotics and address environmental waste concerns
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
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
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.2 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."
"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."
"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
"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
For more information on the AMR standard and certification program, visit: Antimicrobial resistance (AMR) and how standardization is driving change | BSI (bsigroup.com).
Notes to Editors:
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About BSI
BSI is the business improvement and standards company that enables organizations to turn standards of best practice into habits of excellence, 'inspiring trust for a more resilient world'. For over a century, BSI has driven best practice in organizations around the world. Working with over 77,500 clients across 195 countries, it is a truly global business with skills and experience across all sectors, including automotive, aerospace, built environment, food and retail and healthcare. Through its expertise in Standards and Knowledge, Assurance Services, Regulatory Services and Consulting Services, BSI helps clients to improve their performance, grow sustainably, manage risk, and ultimately become more resilient.
About AMR Alliance
The AMR Industry Alliance is one of the largest private sector coalitions created to provide sustainable solutions to curb antimicrobial resistance, with over 100 biotech, diagnostics, generics and research-based pharmaceutical companies and associations joining forces. Alliance members represent the major sub-sectors across the life-sciences industry and have come together toward a common goal to fight AMR. The Alliance is focused on facilitating action in four key areas: access, appropriate use, research & science, and manufacturing.
The AMR Industry Alliance has been a leader in developing and leading implementation of guidance for manufacturers to control emissions of active pharmaceutical ingredients for antibiotics in production wastewater and scale responsible manufacturing practices. Among others, this work has been recognized by the G7 Health Ministers, who also committed to working with the Alliance and other stakeholders to agree to and mainstream standards.
1Antimicrobial Resistance Threatens Development, SDGs: Tripartite Report | News | SDG Knowledge Hub | IISD
2Global burden of bacterial antimicrobial resistance in 2019: a systematic analysis - The Lancet
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SOURCE BSI Group America Inc.
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