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GMP Concept

Annex 6 - Manufacture of Medicinal Gases

This Annex deals with the manufacture of active substance gases and with the manufacture of medicinal gases.

Organisaties:
Pharmaceutical Inspection Co-operation Scheme (PIC/S) EMA
Onderwerpen:
Medicinal Gases

Versietijdlijn

Chronologische releasegeschiedenis

EMA/INS/GMP/371598/2025

Versiemijlpaal

Concept

Publicatiedatum

11 feb 2026

guidelines.detail.timeline.expected_date

Niet opgegeven

Belangrijkste updates: A targeted update of EU GMP Annex 6 is proposed to align it with current industry practice and technology, clarify areas of ambiguity, strengthen quality documentation requirements (e.g., for liquid oxygen supply to hospitals), and consider specific GMP-related aspects for medicinal gases (including batch release processes and facility/containers qualification).
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ENTR/F/2/AM/an D(2010) 3374

Versiemijlpaal

Publicatiedatum

3 feb 2010

Ingangsdatum

31 jul 2010

Belangrijkste updates: This is the current, active version of this annex.
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