Sandoz and Teva Achieve First-Of-A-Kind Manufacturing Certification

In their commitment to tackling global antimicrobial resistance (AMR), the first two Pharma companies have gained independent certification in responsible antibiotic manufacturing.

Sandoz and Teva have become the first organisations to qualify for the new global Minimized Risk of Antimicrobial Resistance (AMR) certification. This programme was developed by the British Standards Institute (BSI) to verify companies that are taking the necessary steps in ensuring responsible antibiotic manufacturing in the global supply chain, helping to lower the spread of AMR.

According to the BSI, all manufacturers of these products are eligible for the AMR certification to gain the BSI Kitemark™, which involves an initial evaluation against the requirements of a designated international standard, published in June 2022.

Impact of the AMR certification

Following the launch of the certification programme’s in June 2023, a range of antibiotic products have successfully completed the certification process within each of the organisations, BSI confirmed.

In an EPR article on the AMR certification published in June, Courtney Soulsby, BSI Global Director, Healthcare Sustainability and Steve Brooks, Manufacturing Working Group Chair for the AMR Industry Alliance shared: “Certification to the Manufacturing Standard has the potential to positively impact global antibiotic supply through antibiotic emission reduction and recognition of the value of responsibly made antibiotics.”

EPR’s June article highlighted that three of the main components of the certification are ensuring a company has: appropriate environmental management system controls in place, evidence of acceptable concentration levels of antibiotics in the environment resulting from manufacturing wastewater, as measured by the AMR Industry Alliance, plus validity verification of the certification via BSI annual surveillance.

Addressing AMR risk in pharmaceutical manufacturing

“This first-of-a-kind certification demonstrates that Sandoz… is taking the necessary steps to ensure responsible manufacturing of [generic antibiotic medicines] – a key pillar of the global AMR response strategy,” stated Boumediene Soufi, Head of Sandoz AMR Program.

“It is fantastic to see Sandoz and Teva achieve certification, making clear their commitment to ensuring antibiotic manufacturing meets the best available scientific and environmental standards. Taking this critical step forward to address the growing threat from AMR and reduce discharge into the environment can help us accelerate progress towards a sustainable world,” Soulsby commented.

date 09/11/2023
Author Catherine Eckford, European Pharmaceutical Review