Minimized risk

of Antimicrobial
Resistance

BSI Kitemark™
for minimized risk
of antimicrobial
resistance

Addressing environmental waste concerns to demonstrate the responsible

manufacturing of antibiotics
According to the World Health Organization, antimicrobial resistance (AMR) has been declared a top 10 global public
health threat and is expected to get worse unless action is taken. It threatens to undermine the basis of modern
medicine by rendering the antibiotics used to treat and prevent infections ineffective.

One cause of antimicrobial resistance is manufacturing waste from the production of antibiotics being released into
the environment, for example through wastewater.

The BSI Kitemark for minimized risk of antimicrobial resistance has been developed to provide independent third
party verification to ensure that emissions from waste streams are effectively controlled.

Leading the way

BSI has developed this certification program, in partnership
with the AMR Industry Alliance (AMRIA), with consultation from
financial investors, non-governmental organizations (NGOs),
government, regulators, and healthcare system procurers who
purchase antibiotics from pharmaceutical manufacturers.
With a stringent qualification of the right assessor
expertise and robust assessment protocols, BSI carries out
assessments on the antibiotic products through an on-going
3-year certification cycle to validate the adherence to the
AMRIA Antibiotic Manufacturing standard and continuous
improvement.
Certification can be awarded to both antibiotic APIs (active
pharmaceutical ingredients) and antibiotic finished drug
products.
• Independent trust for stakeholders (Procurers/
Investors) BSI brings trust into the manufacturer’s
approach in controlling antibiotic discharge
• Provide streamlined evidence for procurers
through a certificate to demonstrate best practice,
rather than large amounts of data that cannot be

By achieving BSI Kitemark certification, manufacturers can compared

demonstrate that their antibiotics have been manufactured • Visibility and control of supply chain showing
with effective controls in place by identifying risk, minimizing
certification of product supply chain at API and final
antibiotic waste entering waste streams, and validating their
drug product stage – simple certificate link in your
data to confirm their Predicted Effective Concentration (PEC)
BSI portal and published on BSI Certification and
is below a threshold level as determined in the Antibiotic
Verification directory
Manufacturing standard.
BSI Kitemark for minimized risk to antimicrobial resistance

What are the benefits

to manufacturers?

Differentiate your products to your customers by

demonstrating compliance to industry created best practice
standard.

Assure internal stakeholders and leadership of the

effectiveness of the control of waste streams for your
operations in relation to minimizing risk of AMR.

Reduce the need for duplicate supply chain audits on

AMR from your customers.

Drive continual improvement in your business practices

to align internal sites on waste control practices, to minimize
the impact of AMR.

What is required to achieve the

Kitemark?
To achieve this Kitemark, BSI will assess manufacturers to
ensure they have:
• Implemented the AMR Industry Alliance standard
• Implemented select parts of ISO 14001
• A consistent method to calculate their PEC
Trust and confidence with
the BSI Kitemark
For more than 100 years, the BSI Kitemark™
has been recognized as a symbol of
outstanding quality, safety and trust
across a wide range of products and
services.

Kitemark certification confirms that a product or service’s

Copyright © 2023. The British Standards Institution

claim has been independently and repeatedly tested by
experts, meaning that you can have trust and confidence in
products and services that are BSI Kitemark certified.

To discover more about the BSI

Kitemark visit: bsigroup.com