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Environmental Aspects of Manufacturing for the Prevention of Antimicrobial Resistance

The environment plays an important role in antimicrobial resistance (AMR)This is interesting bridge document between GMP and Environment. Here discuss about the points to consider for manufacturers and inspectors for environmental aspects of manufacturing for the prevention of antimicrobial resistance.

Microorganisms in soil, rivers and seawater can develop resistance through contact with resistant microbes (transfer of resistance genes), antibiotics and disinfectant agents released by human activity, as well as heavy metals that may propagate AMR in the environment. People and livestock could then be exposed to more resistant bacteria through food, water and air.

 Pharmaceuticals entering the environment from industrial manufacturing activities are not the major source of antimicrobial resistance, but in countries that contribute the most to the production of antimicrobials, this issue can be significant. 

The levels of pollution with antimicrobials have been measured in waters in the proximity of pharmaceutical production facilities. 

Antimicrobial concentrations in some effluents are too low to be lethal to exposed bacteria but may still be sufficient to induce antimicrobial resistance, but high concentrations have been found downstream of antimicrobial manufacturing sites in several countries. Scientific literature reports a correlation between the type and number of highly resistant bacteria and the level of antimicrobial pollution. This led to manufacturing sites being identified as one of the hot spots for development of AMR.

The purpose of this document is:

  • provide recommendations and expectations for manufacturing facilities for medicines regarding waste management, to mitigate/ prevent potential antimicrobial resistance;
  • raise awareness of medicines’ manufacturers, national regulatory authorities (NRAs) and especially GMP inspectorates and inspectors in all Member States, on sections of relevant GMP guidance that are applicable to the management of waste/wastewater from the production of antimicrobials, while emphasizing the importance of all aspects of GMP implementation and considering the parts of GMP that may not have a direct impact on product quality;
  • provide clarification on the interpretation of those clauses and specific measures that should be taken to be considered compliant with the relevant sections of #GMP guidance, without changing the scope of GMP.

Reference: Annex 6, WHO Technical Report Series, no. 1025.

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