New AMR Certification Launched for Antibiotic Manufacturers
Following publication of the Antibiotic Manufacturing Standard in 2022 to help overcome AMR, antibiotic manufacturers can now verify their actions through a new certification.
This article was originally published by European Pharmaceutical Review.
A new global Minimized Risk of Antimicrobial Resistance (AMR) certification has been launched to promote and demonstrate responsible antibiotic manufacturing in the global pharmaceutical supply chain.
BSI, a UK standards body, developed the new certification to the Antibiotic Manufacturing Standard published in June 2022.
Following this “ground-breaking standard” stated Courtney Soulsby, BSI Global Director for Healthcare Sustainability, the certification will “promote responsible pharmaceutical manufacturing and help protect the natural environment and slow antimicrobial resistance”.
Being certified facilitates independent third-party verification that waste streams containing antibiotic active pharmaceutical ingredient (API) and drug products are appropriately controlled during manufacturing by pharmaceutical companies.
How will the Antimicrobial Resistance certification work?
The certification programme will involve initial evaluation against the requirements of the standard plus annual surveillance to verify ongoing maintenance of the appropriate controls over time.
After initial launch, all antibiotic manufacturers globally will be eligible to obtain the certification.
— AMR IndustryAlliance (@AMRAlliance) June 6, 2023
Pilot programme to support antibiotic waste control measures
Big Pharma companies are 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 programme. These include Pfizer, Roche, Sandoz and Teva.
“Pfizer was delighted to participate in the pilot [scheme] for this new certification programme to help ensure appropriate control of antimicrobial manufacturing waste, and looks forward to its adoption across the pharmaceutical industry,” stated Dermot Dolan, Internal Audit & Supplier Operations EHS Lead at Pfizer.
As well as 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.
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. 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.”