WHO offers guidance on reducing antimicrobial waste from manufacturing sites
The World Health Organization (WHO) has proposed new guidance to limit antimicrobial waste from manufacturing plants that produce antibiotics. The proposal aims to curb antimicrobial resistance (AMR) and reduce the ecological effects caused by discharges of antibacterial agents into the environment.The 47-page document establishes a framework for manufacturers to manage these discharges from antibiotic manufacturing facilities.
According to a WHO announcement, “Antibiotics provide great value to humanity to prevent and treat infectious disease. However, environmental emission of antibiotics during manufacturing has potential to contribute to the emergence and spread of AMR. Therefore, there is a recognised need, stemming from a World Health Assembly resolution and the Global Action Plan on AMR, for international evidence-based guidance and tools on the management of manufacturing waste containing antimicrobials to guide the target audiences of this document.”
This guidance covers three core elements: it defines health-based targets based on exposure and risk assessment, establishes risk management process to reach those targets using hazard analysis and critical control points (HACCPs), and proposes surveillance audits to ensure targets are being met.
As part of setting health-based targets, the guidance sets limits for liquid effluent as well as solid waste. Effluent water quality targets are expressed as Predicted No Effect Concentrations (PNECs) for resistance selection and for ecological effects.
The document also describes the management process manufacturers should follow to identify and manage risks to limit antimicrobial emissions in wastewater to ensure such waste meets specified targets.
It describes identifying hazards that may release antibiotics into waste streams. The guidance states that “with the production flow mapped, key processes that contribute to the release of antibiotics and their active intermediates into the effluent stream need to be identified and should include both process-related and equipment-related risk factors. This can involve quantification using mass-balance calculations.”
Manufacturers are also instructed to identify potential sources of accidental antibiotic or antibiotic intermediate release to the effluent stream at each stage of the production process. The guidance specifies that “this may include leaks in storage and pipes, spills, improper handling or storage of chemicals, as well as inadequate containment measures.”
The guidance further proposes that manufacturers regularly monitor the overall performance of the manufacturing system and ensure that the controls in place are working effectively.
It recommends that manufacturers conduct an audit to verify compliance under these limits and recommends that third parties can also conduct such auditing.
The guidance complements the WHO Good Manufacturing Practices (GMP) and the “TRS 1025 - Annex 6: Points to consider for manufacturers and inspectors: environmental aspects of manufacturing for the prevention of antimicrobial resistance.”
The guideline was also accompanied by a background document which describes the criteria for deriving the PNECs for effluent in water.
The deadline for commenting is 26 January.
WHO guideline, Background document
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