EMA: Revision of Annex 6 - Manufacture of Medicinal Gases
EMA and PIC/S have published a concept paper announcing a targeted revision of Annex 6 Manufacture of Medicinal Gases of the EU GMP Guide. The last update dates from 2010. The revision aims to reflect current manufacturing practice, technological progress and lessons learned from the COVID-19 pandemic.
Key elements under discussion
The revision will be focused and limited in scope, addressing in particular:
- Premises
requirements
Reassessment of the applicability of general GMP requirements to closed, pressurised gas manufacturing systems. - Technological
developments
Consideration of modern safety features such as gas-specific couplings, elimination of containers without residual pressure valves and adapted valve/residual gas checks to reduce contamination risks. - Cylinders
with integrated pressure regulator flowmeters
Clarification of inspection requirements before and after refilling and definition of control frequencies; inclusion of cryogenic containers. - Medicinal
liquid oxygen supply to hospitals
Strengthening and clarification of documentation and quality assurance requirements for the filling of the hospital’s tank evaporation units. - Batch
certification (in addition to Annex 16)
Assessment of potential specific provisions for medicinal gases, including QP availability and possible remote certification aspects. - Qualification
of facilities and containers
Clarification regarding qualification of production plants, mobile/stationary tanks and reusable containers.
Timeline
- Public consultation until 11 April 2026
- Draft guideline: November 2026
- Finalisation: 2027
Quelle:
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