13/14 December 2023
The World Health Organization WHO has published a draft document on "Environmental Aspects of GMP: points to consider for manufacturers and inspectors in the prevention of antimicrobial resistance".
With this working document the WHO plans to include the topic of waste and wastewater management into their GMP Guidance: it "addresses the current needs for guidance on how GMPs should be implemented to waste and wastewater management for production of antimicrobials, with a focus on Critically Important Antimicrobials."
This initiative could raise concerns with national competent authorities and within industry. The underlying problem is that most active substances (APIs) are produced in countries with weak environmental legislation. An appropriate initiative would be advisable. The WHO therefore means well, but is perhaps wrong to link this to GMP. One will see what the feedback will be from those who have the World Health Organization's permission to do so.
The document entitled "Environmental Aspects of Good Manufacturing Practices: Points to consider for Manufacturers and Inspectors in the Prevention of antimicrobial Resistance" can be commented until 14 June.