A COLLABORATIVE INITIATIVE FOR RESPONSIBLE ANTIBIOTIC MANUFACTURING AND ENVIRONMENTAL PROTECTION
sciences sector, the Alliance played a pivotal role in developing this globally applicable industry standard. This united effort underscores a shared dedication to sustainable solutions in addressing AMR challenges and emphasizes the paramount importance of responsible antibiotic manufacturing.
The blueprint: key aspects of the AMR certification The AMR certification, designed by BSI to complement the Antibiotic Manufacturing Standard, provides an independent, third-party verification of stringent controls over waste streams containing antibiotic active pharmaceutical ingredients (APIs) and drug products throughout their manufacturing journey. This rigorous certification process includes an initial evaluation and an ongoing annual surveillance mechanism, ensuring continuous alignment with the standard's exacting requirements.
Industry leaders in action: the early adopters Distinguished pharmaceutical companies, including Centrient, Pfizer, Roche, Sandoz, Teva, Viatris, and Haupt Pharma Latina, have embraced the certification program as early adopters. Their participation underscores the
industry-wide commitment to driving responsible antibiotic manufacturing practices. It serves as a resounding endorsement of the potential of this certification to catalyze transformative change.
A sustainable vision: integrating antibiotic waste controls Through partnership with the AMR Industry Alliance and participating companies, the BSI's certification program advocates for the integration of sustainability principles into pharmaceutical operations. Aligning waste control strategies with broader sustainability objectives, antibiotic waste controls are becoming a crucial criterion in commercial tenders within healthcare systems. This holistic approach reflects the industry's resolve to balance medical advancement with environmental preservation.
Facing the AMR challenge together: voices of industry leaders The perspectives of industry leaders resonate with the urgency of addressing AMR. Courtney Soulsby, BSI Global Director, Healthcare Sustainability 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.”
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.”
James Anderson, Chairman of the AMR Industry Alliance said, “Ensuring antibiotic manufacturing meets best available scientific standards is an important tool in tackling the rise of antimicrobial resistance. The launch of the certification programme 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. 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."
Dermot Dolan, Internal Audit and Supplier Operations EHS Lead at Pfizer said, “Pfizer was delighted to participate in the pilot programme for this new certification to help ensure appropriate control of antimicrobial manufacturing waste and looks forward to its adoption across the pharmaceutical industry. Responsible manufacturing of antimicrobials is key to help curb the global health threat of AMR, and we are committed to continuing our leadership in this area.”
A unified front against AMR The introduction of the AMR certification stands as a beacon of hope in the battle against drug- resistant infections. By unifying efforts across sectors, the world takes a definitive step toward curbing AMR's rise, ensuring the sustained efficacy of antibiotics, protecting both public health and the environment.
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