Companies take hands-on approach to suppliers’ wastewater management practices

A major yet often overlooked driver of antimicrobial resistance (AMR) is the release of active pharmaceutical ingredients (APIs) from antibiotic manufacturing into the environment. When wastewater containing this residue enters local ecosystems, it can create breeding grounds for bacteria that become resistant to antibiotics, putting people at risk and making vital medicines less effective. 

Antibiotic manufacturing occurs within highly fragmented supply chains, with production sites located around the world. Without proper wastewater management, these facilities can become key points of antibiotic release into the environment. Pharmaceutical companies can reduce the risk of AMR by enforcing robust manufacturing standards not only at their own sites, but also at those of suppliers, who often produce APIs and drug products on their behalf.  

As the main customers and coordinators in these supply chains, companies have the ability and responsibility to ensure supplier compliance with recommended discharge limits, helping to protect people in local communities and prevent the spread of AMR. 

These companies are demonstrating a willingness to go the extra mile in preventing antibiotic pollution across supply chains

Efforts aim to ensure discharge compliance across supply chains 

Six companies – Abbott, Aurobindo, Cipla, GSK, Sandoz and Shionogi – are taking a more active role in engaging their suppliers to comply with discharge limits via different practices.Outlined by the AMR Industry Alliance (AMR IA) Antibiotic Manufacturing Standard and World Health Organization (WHO) guidance, these limits aim to minimise the risk of resistance and environmental harm. 

Company efforts generally take two forms: offering additional support to suppliers to achieve compliance and including AMR-related waste provisions in supplier contracts. The six companies highlighted here were selected because they demonstrate strength in these areas – or have high levels of supplier site or product compliance. By extending oversight and deepening engagement beyond their own facilities, these companies are demonstrating a willingness to go the extra mile in preventing antibiotic pollution across supply chains. 

What types of additional support are companies offering suppliers? 

All six companies take the standard approach of asking suppliers to implement corrective actions themselves when discharge limits are exceeded or require an audit every one to three years. However, five companies go further by helping suppliers measure and achieve compliance through additional practices.  

• Abbott offers free wastewater analysis to all suppliers whose estimated antibiotic discharges are higher than the safe limit, based on mass balance calculations. 

• Cipla conducts workshops with suppliers on how to quantify discharge levels with mass balance calculations, in line with the AMR IA Standard. 

• GSK tailors engagement plans for each supplier and conducts desktop-based assessments to evaluate adherence to discharge limits. When non-compliance is identified, it provides one-on-one support with mass balance calculations and guidance on adjusting waste management processes to meet limits. 

• Sandoz collaborates with suppliers through its audit and relationship management teams to create corrective and preventive action (CAPA) plans when antibiotic concentrations in wastewater go beyond safe levels. 

• Shionogi helps each of its suppliers determine the most appropriate methods for quantifying antibacterial discharges, based on their specific facilities and equipment.  

These more targeted, tailored practices demonstrate a proactive and collaborative approach to responsible manufacturing, with companies educating and supporting suppliers at different stages to improve discharge management. 

Contract provisions can also bolster compliance 

Apart from Cipla, all companies include discharge-level compliance expectations in supplier contracts. These provisions are guided by recognised industry initiatives, such as the Pharmaceutical Supply Chain Initiative (PSCI) framework* and the AMR IA Standard. They refer to the assessment and control of antibacterial discharges to ensure they remain below the predicted no-effect concentrations (PNECs) – the levels at which antibiotics are unlikely to cause environmental or resistance-related harm.  

Including such provisions can help strengthen accountability across supply chains and ensure that manufacturing and environmental standards are enforceable rather than just voluntary. 

Extra measures yield results, setting example for others to follow 

Among the four companies that report supplier compliance, performance is consistently high – showing that the more active supplier engagement pays off. Specifically, Aurobindo, GSK and Sandoz report 100% compliance, and Shionogi reports compliance for five out of seven products made by its suppliers. 

Taking this progress forward  

By proactively ensuring supplier compliance with discharge limits – through contractual provisions, additional support or, ideally, both – companies can more effectively strengthen responsible manufacturing across supply chains. Combining both approaches not only set clear expectations but also give suppliers the guidance and tools they need to actually deliver on them.  

While most of the companies referenced in this Best Practice report being compliant with discharge limits in the receiving environment (i.e., rivers and waterways), ensuring compliance before the release of wastewaters into the environment would further help protect ecosystems and communities worldwide. This would be in line with measures recommended by WHO. Collectively, the industry should work towards this, as mitigating antibiotic discharges at the source can improve control of AMR and safeguard global health.