Skip to main content Skip to search Skip to main navigation

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

 

Meet the GMP Compliance Adviser

The GMP Compliance Adviser is the world's largest knowledge portal for quality management in the pharma business. 

The demo access is non-binding and ends automatically.

Test it now for free

You may also be interested in the following articles:

FDA: New Draft Guidance on Impurity Specifications for Antibiotics

FDA: New Draft Guidance on Impurity Specifications for Antibiotics

The US FDA has issued a new draft guidance (April 2026) on Impurity Specifications for Antibiotics.
Read more
EDQM: Guidance on Traceability of Medicines in Hospitals

EDQM: Guidance on Traceability of Medicines in Hospitals

The EDQM has published new guidance on the traceability of medicines in hospital settings. The aim is to improve traceability up to the point of administration and strengthen patient safety.
Read more
Contamination Control Strategy (CCS) – Not Just an Extended Site Master File

Contamination Control Strategy (CCS) – Not Just an Extended Site Master File

At the GMP-PharmaCongress in Wiesbaden, GMP inspector Frank Sielaff (Regional Authority in Darmstadt, Germany) shared practical insights from recent inspections, high-lighting deficiencies in CCS implementation.

Read more
Which Measures are Crucial for Implementation and Monitoring of Data Integrity?

Which Measures are Crucial for Implementation and Monitoring of Data Integrity?

Here's the answer:
Read more
EMA/HMA: Call for Regulatory Updates for Radiopharmaceuticals

EMA/HMA: Call for Regulatory Updates for Radiopharmaceuticals

In their „Horizon Scanning Report“, EMA and HMA have recommended updates to the regulatory framework to keep pace with developments in radiopharmaceuticals. Due to their unique characteristics these products require specific regulatory and scientific approaches.
Read more
How can the Specific Requirements for Sterile Products be Taken into Account in the Quality Management System?

How can the Specific Requirements for Sterile Products be Taken into Account in the Quality Management System?

Here's the answer:
Read more
Previous
Next