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Medicinal gases guidance

Version 2.0, January 2019

15 January 2019

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Quality control (Chapter 6)

Reference and retention samples

Reference and retention samples (clause 6.14) for medicinal gases are not required, as outlined in Annex 6 clause 43, and therefore compliance with this clause is not expected.

Method validation

Method validation (clause 6.15) is not normally required where official test methods outlined within the default standards, (BP, Ph. Eur. or USP) are adhered to.

Ongoing stability

Ongoing stability programmes (clauses 6.26 - 6.36) for medicinal gases are not generally required, as outlined in Annex 6 clause 44. If stability requirements are detailed in the market authorisation of a product, then ongoing stability testing may be necessary.

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