WHO Guidance on Wastewater and Solid Waste Treatment in the Antibiotics Production

Antibiotic resistance jeopardises the effectiveness of vital medicines. Environmental pollution with antibiotics contributes to antibiotic resistance and potentially undermines the effectiveness of medicines produced at the same site. Nevertheless, high concentrations of antibiotics in receiving waters at production sites have been widely documented. Currently, this type of pollution is not globally regulated and GMP quality assurance criteria typically do not include such environmental emissions.

The WHO has published a new guideline on the control of environmental pollution in the production of antibiotics. The aim is to minimise the spread of antibiotic resistance through science-based recommendations. The focus is on wastewater treatment and the proper disposal of solid waste from antibiotic production. The new guideline aims to minimise the risk of resistance development through controlled wastewater and waste disposal worldwide.

The new guideline is aimed at the following stakeholders:

• Regulatory authorities (national and regional),
• Pharmaceutical manufacturers and their supply chains,
• Operators of wastewater treatment plants
• Service providers for audits and certifications,
• Investors in the pharmaceutical sector.

The 80-page document describes important measures in this regard. Waste containing antibiotics or antibiotic-resistant bacteria must be disposed of safely:

1. Waste water: The directive provides for limit values for antibiotics in liquid waste water based on predicted no-effect concentrations (PNECs). The installation of various water treatment technologies such as oxidation with ozone or the use of membrane bioreactors is discussed.
2. Solids: This includes thermal treatment or safe landfilling in specialised facilities. For waste from fermentation, at least 99% of antibiotic residues must be removed.
3. Wastewater-free production: The concept of 'Zero Liquid Discharge' (ZLD) is discussed, i.e. all liquid waste is recycled in the plant so that no pollutants are released into the environment.
4. Monitoring and audits: The guide calls for internal and external audits to ensure compliance and limits. Third-party providers should check the performance of wastewater and waste treatment and issue certifications.

The WHO recognises that implementation requires time and resources. The guide therefore proposes a step-by-step approach that incentivises companies that adapt to stricter standards early on and outlines the following long-term goals:

• Protecting the environment: Avoiding the release of resistance-promoting antibiotics into ecosystems.
• Strengthening antibiotic efficacy: Limiting the global spread of antibiotic-resistant bacteria.
• Transparency and responsibility: The industry should have its production processes monitored and strive for continuous improvements in waste treatment.

You can find the entire document on the WHO website.