News about GMP/cGMP

19.02.2021

WHO: Draft Guideline on Medical Gases

The WHO published a 29-page draft guideline on Good Manufacturing Practices for Medical Gases in February 2021. The reason given for this step is a sharp increase in the demand for medical gases, particularly oxygen used to provide respiratory care to covid patients.

The future guideline is mainly intended to provide all WHO Member States with appropriate quality standards for the manufacture, control, storage and distribution of medical gases. It does not cover the manufacture of medical gases in hospitals.The draft is based on existing EU and PIC/S documents, both in terms of structure and content, although not in such depth.

The comment period is open until March 30, 2021. Given the current urgency, the guideline is expected to be finalized already by October 2021.


Source:

WHO Draft: Good Manufacturing Practices for Medical Gases

 



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