Home » Antimicrobial Resistance » Why a new certification is setting the standard for antibiotic manufacturers

Courtney Soulsby

Global Healthcare and Life Sciences Director, BSI

Natasha Bambridge

Global Director Consumer Promise Practice, BSI

Antibiotic manufacturers can be awarded a new certification — if they demonstrate that they are minimising the risk of antibiotic waste entering the environment.

The British Standards Institution (BSI) has developed a new certification programme called the ‘BSI Kitemark™ for minimised risk of antimicrobial resistance.’

Potential risks in antibiotic manufacturing

It’s been well-publicised that the overuse and misuse of antibiotics are major factors in the spread of antimicrobial resistance (AMR), a global health threat that the World Health Organization says could have catastrophic implications for the treatment and prevention of infections.

What may be less publicly known is that the antibiotic manufacturing process itself can also unwittingly facilitate the spread of AMR. The issue can occur when manufacturing waste that includes high levels of antibiotic residues is released into the natural environment — for example, via wastewater.

“There are a number of stages in the production of antibiotics where aquatic waste is created,” explains Courtney Soulsby, Global Healthcare and Life Sciences Director at BSI, the business improvement and standards company. “For instance, when manufacturing lines are cleaned, when products are distilled or when fermentation processes are used.” If aquatic waste escapes from an antibiotics manufacturing plant and into waste streams, it can ultimately end up in wastewater treatment.

Demonstration of effective controls

With the Kitemark certification, antibiotics manufacturers are able to show that they have effective controls in place to minimise the concentration of antibiotic waste entering the environment. “This is assessed via a complex engineering calculation — to arrive at the PNEC (predicted no-effect concentration), concentration of antibiotic residue, below which adverse effects (AMR) in the environment are not expected to occur,” reveals Soulsby.

“Manufacturers have implemented the AMR Industry Alliance standard and then self-declaring their compliance. From a regulatory point of view, it’s not a requirement; manufacturers want to raise the bar and be independently assessed,” explains Natasha Bambridge, Director of Consumer Promise Practice. “While the certification is voluntary, our hope is all stakeholders in the healthcare ecosystems adopt it to support the AMR cause.”

With the Kitemark certification, antibiotics manufacturers are able to show that they have effective controls in place to minimise the concentration of antibiotic waste entering the environment.

How the certification was developed

The creation of the Kitemark™ has been years in the making. As manufacturers all have their own criteria to assess the effectiveness of their environmental controls, it was obvious that a standardised approach could bring benefits to people and the planet. BSI facilitated the development of a standard of best practice, on behalf of the AMR Industry Alliance, for the responsible manufacture of antibiotics.

“The Antibiotic Manufacturing Standard was published in June 2022,” reveals Soulsby. “Subsequently, we brought a number of stakeholders around a table — including regulators, government policymakers, health system procurers, NGOs and manufacturers — to develop the certification programme that could assess manufacturing controls consistently and at scale, based on the requirements in the Standard.”

Important role of healthcare procurers

The new Kitemark™ was rolled out in June 2023, and Bambridge says it is already having an impact. “Four organisations that went through the pilot process and helped us to shape the certification programme now have certified antibiotic products, including Sandoz and Teva,” she says.

“Other pharmaceutical organisations are declaring that they are in the process of becoming certified, so they can win new business through healthcare systems’ antibiotic tenders. They know they can differentiate themselves from their competition by having better controls in place and ensuring they have a positive impact on the environment.”

The way the Kitemark has been positively welcomed on the healthcare system/procurement side can bring significant benefits to society. “Healthcare systems are starting to reference both the Standard and the certification within their environmental award criteria for antibiotic procurement tenders,” says Bambridge.

“That’s gratifying to see. Healthcare procurers can play a central role in driving the certification forward — both for the new innovative antibiotics of the future and, crucially, for the generics representing the large volume of antibiotics on the market today. That represents a critical step forward to address the growing threat of AMR and reduce discharge into the environment.”

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