Barry O’Neill, EHS manager at Gaelic Laboratories, explains the role of pharma manufacturers in managing the spread of AMR, and the steps they should take to do this effectively.
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The World Health Organisation (WHO) has identified antimicrobial resistance (AMR) as one of the top 10 global public health threats, potentially responsible for more than 1.27 million deaths annually. Over-prescribed antibiotics in primary care are a frequently-cited cause of AMR, but other important sources include run-offs from plant and animal agriculture, pollution from hospital and community wastewater, and other forms of waste and releases – including those from manufacturers of antibiotics. Emissions of antibiotics from manufacturing sites have the potential to select for resistant bacteria and may contribute to the emergence of new forms of resistance in pathogens.
This highlights the significance of AMR stewardship within antibiotic manufacturing. Pharmaceutical manufacturers have an important role to play in controlling AMR, as recognised by the formation of the AMR Industry Alliance in 2017. The AMR Industry Alliance is one of the largest private sector coalitions to provide sustainable solutions to curb AMR, with over 90 biotech, diagnostics, generics and research-based pharmaceutical companies joining forces to encourage and implement responsible antibiotic manufacturing and environmental protection.
Manufacturing standard and framework
In 2025, the AMR Industry Alliance updated its Antibiotic Manufacturing Standard (originally published in 2022). This latest edition of industry guidance marks a new gold standard for responsible antibiotic manufacturing, including stricter waste management, API discharge limits, and greater supply chain transparency.
The new requirements reflect the most recent scientific research, such as that led by the Alliance to establish Predicted No-Effect Concentrations (PNECs) to serve as targets for wastewater effluent risk assessments. A list of PNECs for at least 125 antibiotics has now been established and is updated annually. The new research also derived a default PNEC of 0.05 µg/L for any unlisted antibiotics (in the absence of other data).
These scientific findings, and the updated Manufacturing Standard, form the basis of a BSI Kitemark which provides the only independently certifiable assessment for responsible antibiotic production. Organisations aiming to demonstrate adherence to the AMR Industry Alliance’s Manufacturing Standard can pursue the BSI Kitemark for Minimised Risk of AMR. This certification demonstrates a commitment to promoting responsible antibiotic manufacturing.
Over the past 12 months, Gaelic Laboratories has been working to achieve this certification. Using an approach primarily based on the AMR Industry Alliance Manufacturing Standard and the associated framework used by BSI during the assessment and certification process, the company received its BSI Kitemark certification in May 2026. This meant ensuring that antibiotic API and drug product manufacturing areas, with a particular focus on wastewater treatment facilities and waste storage locations, are designed, operated and maintained to minimise discharges of antibiotics to the environment.
From a site perspective, compliance with these guidelines involves a combination of operational controls, environmental risk management, governance improvements, monitoring activities, procedural strengthening, and cross-functional engagement across manufacturing, engineering, quality, environmental health and safety, and laboratory operations. Our experiences and advice are shared in this article, to help other companies embarking on their AMR risk management journeys.
Wastewater management
Concentrations of pharmaceuticals in industrial effluents can be several orders of magnitude greater than the concentrations found in sewage effluents. High emissions of antibiotics from manufacturing plants have been reported, so AMR stewardship places a strong emphasis on the appropriate management of wastewater effluent.
At the most basic level, antibiotic manufacturing sites must have controls in place to manage the risks associated with discharges of wastewater containing antibiotic APIs and/or drug products. Antibiotic residues in wastewater need to be quantified and evaluated against environmental protection criteria to measure risk – that means ensuring any possible residues fall below the PNEC defined for any particular antibiotic, and the site’s SOP should include a calculation for predicting the environmental concentration of any pollutants through mass balance, sampling and analysis, or zero liquid discharge.
Wastewater effluent monitoring involves the collection, analysis and management of wastewater discharged from manufacturing facilities by assessing the composition of the effluent, determining the presence of antibiotics and other contaminants (relative to relevant PNEC values), and implementing measures to avoid the release or spillage of any polluted water. One approach, if available, is to perform regular routine testing by an in-house expert lab team, complemented by additional independent testing at an external local council treatment platform. Such a dual testing approach ensures that – should any accidental leakages occur – they would be quickly detected and dealt with appropriately. The site’s SOP must include spill response and management procedures, just in case something goes wrong.
In terms of investment, there were upgrades and improvements made in areas such as environmental controls, monitoring capability, containment practices, wastewater-related controls, and supporting systems and processes. Although Gaelic Laboratories is a new company, founded just in 2022, the manufacturing site is about 50 years old and antibiotics have been produced at the location since the 1970s. This means that when the new leadership took over the plant in 2022, they invested in a large amount of new equipment that met modern standards and were already closer to meeting those required by the BSI for the current exercise.
For example, the Gaelic Laboratories site has within the past 2 years received a new monitoring station for effluent wastewater, as well as an upgraded extraction system that ensures any API air particulates don’t end up in wastewater. The entire site was also utility-mapped because the previous owners had no record of drain locations, and the new leadership obtained a trade effluent licence from the local authority to ensure that the company is compliant with local regulations.
Solid waste
Antibiotic manufacturing sites must have controls in place to manage the risks associated with the disposal of solid wastes containing antibiotic APIs or drug products. To begin with, solid waste potentially containing any active ingredients must be gathered safely and in a controlled manner, so the newly upgraded extraction system is crucial in ensuring any particulates are consolidated and gathered as solid waste. On the site, that waste must be stored in a manner that prevents discharges and unsafe conditions.
Once the solid waste leaves the manufacturing site, it remains the responsibility of the manufacturer to make sure that any waste disposal contractors possess authorisations or certifications from relevant local regulatory authorities to manage antibiotic wastes.
For example, in order to satisfy these criteria and ensure responsible disposal of solid waste from its manufacturing site, Gaelic Laboratories works with a specialised hazardous waste treatment company that has expertise in managing the most complex waste streams, including medical and pharmaceutical solid waste. The waste treatment company collects the solid waste and transfers it securely to a central treatment plant, where all waste and possible contaminants are incinerated in dedicated installations. The company provides due evidence of destruction for Gaelic Laboratories’ records.
For normal, non-hazardous waste, Gaelic Laboratories uses a municipal sorting facility, which sorts the waste into recyclable fractions or uses it as solid recovered fuel (SRF). Therefore, none of our waste goes to landfill.
However, for other companies that send their waste to landfill, it is worth noting that the AMR Industry Alliance Manufacturing Standard has clear guidance on antibiotic waste that is to be landfilled. In these cases, the manufacturer must verify that the intended landfill site has confirmed that it is designed and operated in a manner that prevents the release of antibiotics into the environment.
Multiple site functions
In addition to the Gaelic Laboratories site in Clonmel, County Tipperary in Ireland, there is a sister company Athlone Laboratories, which is situated in Ballymurray, in County Roscommon. Both companies are GMP-approved manufacturers of Beta-Lactam antibiotics, with multiple operational and business synergies that enhance their contract manufacturing offering. A key focus of their integration has been the alignment and harmonisation of the two companies’ manufacturing processes.
This means that as the Clonmel site has been upgraded to comply with the AMR Industry Alliance Manufacturing Standard, similar work has been implemented at the site in Ballymurray, to ensure that both can claim similar gold-standard level practices in terms of minimising the risk of AMR from their manufacturing activities. This collaborative effort has streamlined upgrades across the two sites.
Conclusion
BSI Kitemark Certification for Minimised Risk of AMR aligns with wider sustainability and compliance objectives. More pharma companies are committing to a more sustainable, circular model, reducing waste and resource depletion. This involves incorporating environmental responsibility into every process, from recycling waste streams and the sourcing of green energies, to re-shoring programmes and the use of recyclable materials wherever possible.
In addition to this, the BSI’s independent endorsement for responsible monitoring and management of wastewater and solid waste, in a manner that complies with the global gold standard for preventing AMR in antibiotic manufacturing, provides important additional guarantees of responsibility and sustainability to partners and customers.
As Gaelic and Athlone Laboratories continue on this path, they join a growing number of responsible antibiotic manufacturers that share the goals of providing critical medicines for patients, while leveraging best-practices to support a broad industry momentum to fight AMR.