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Australia: TGA Issues Revised Medical Gases GMP Guidance

Regulatory Update | Posted: 25 June 2012

By Ansis Helmanis, RegLink

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Australia’s Therapeutic Goods Administration (TGA) has issued guidance concerning the applicability of the 2009 Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co- operation Scheme (PIC/S) Guide to Good Manufacturing Practice for Medicinal Products to the production of medicinal gases.

The new guidance replaces the TGA’s earlier interpretation of the 2002 PIC/S GMP guidance. The revised interpretation was developed in cooperation with Australia’s medical gas manufacturers.

TGA – PIC/S Guide to Good Manufacturing Practice for Medicinal Products

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Australia: TGA Issues Revised Medical Gases GMP Guidance

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