Medical Gases: WHO publishes Draft Guideline

In February 2021, the WHO published the new Guideline "GOOD MANUFACTURING PRACTICES FOR MEDICAL GASES" on the manufacture, testing, storage and distribution of medical gases for comment. The reason for the WHO to create this new guideline is the increased demand for oxygen for ventilation due to the Corona pandemic.

In addition to an introduction and a glossary the draft comprises the following chapters:

  • Quality management 
  • Personnel 
  • Documentation 
  • Complaints 
  • Recalls 
  • Returns 
  • Self-inspection 
  • Premises 
  • Equipment and utilities 
  • Qualification and validation 
  • Production 
  • Quality control 
  • Product life cycle and continuous improvement 
  • Storage and distribution

The chapters correspond to the quality assurance elements known from the GMP world, with simplified content, of course. For example, the Qualification & Validation chapter is very brief. It simply requires that the scope of qualification & validation should be risk-based and that building, equipment, process, filling, storage and transport should be considered.

For more details please the document itself - "GOOD MANUFACTURING PRACTICES FOR MEDICAL GASES" - which can be found on the WHO website in the area working documents in public consultation.

The comment period runs until the end of March. Completion is scheduled before the end of 2021.

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