The World Health Organization (WHO) issued a draft document Wednesday on environmental aspects of good manufacturing practices (GMP) to aid inspectors and manufacturers of antimicrobials.
The 24-page document is intended to raise awareness on interpreting relevant GMP guidance sections applicable to managing waste and wastewater from antimicrobials’ production, considering all GMP implementation aspects and focusing on critically important antimicrobials to establish and enforce requirements on safe waste and wastewater disposal. The draft also proposes ways to control and reduce the contamination of environments with antimicrobials and chemicals from production processes.
The move forms part of WHO’s response to the threat of antimicrobial resistance (AMR). WHO seeks input on the draft, including the proposals for ways to combat AMR when manufacturing drugs.
WHO explains AMR is a broader term than antibiotic resistance because AMR encompasses resistance to drug treatments of bacterial infections caused by more microbes such as parasites, whereas antibiotic resistance is limited to bacteria. But both have been spreading in recent years, posing a global crisis.
“We may be entering a post-antibiotic era where simple and previously treatable bacterial infections can kill and where routine medical procedures that rely on antibiotic preventative treatment, such as joint replacements and chemotherapy, will not be possible,” says WHO. “Poor control of waste and wastewater, such as that encountered in some of the countries who are major global producers of APIs and FPPs, can often lead to the entry of antibiotics into waters that are contaminated with pathogenic bacteria from untreated sewage. This increases the risk of the development of antimicrobial resistance.”
The focus of the draft document relates to the potential for GMPs to prevent waste in the environment when fully implemented. WHO largely points to 2010 GMP guidelines
for pharmaceutical products containing hazardous substances. Still, the draft proposes to update its guidelines based on certain considerations.
WHO’s Prequalification Team Inspectorate also intends to pilot a process in which to include adequate measures to prevent contamination of environments with antimicrobials. The pilot process is set to launch next year with a focus on critically important antimicrobials manufactured at API and FFP plants.
“Approximately one year after its launch, the effectiveness of this pilot process will be monitored to decide whether or not it should be modified, strengthened or expanded,” WHO adds.
The draft document follows on the heels of WHO’s final report
on recommendations to combat AMR.