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PE009-13, the PIC/S guide to GMP for medicinal products

TGA interpretation and expectations for demonstrating compliance

2 January 2018

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Medicinal gases (Annex 6)

Bulk, liquefied medical gas manufacturer exemption

All entities involved in the manufacture of medicinal gases are required to hold a TGA licence and meet PIC/S GMP requirements (including Annex 6), except those entities responsible for the manufacture of bulk, liquefied medical gases, as they are exempt from GMP licensing requirements under item 17 of Schedule 7 of the Therapeutic Goods Regulations 1990. Any step of manufacture, prior to receipt of the bulk gas is not subject to GMP requirements, including where bulk liquefied gases are produced on site.

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