This guidance
This guidance is for manufacturers of registered medicinal gases. It explains our interpretation and expectations for compliance with specific sections of the PIC/S Guide to Good Manufacturing Practice for Medicinal Products PE009-13 (PIC/S Guide to GMP).
TGA has adopted the PIC/S Guide to GMP, PE009-13 (excluding Annexes 4, 5 and 14), taking effect on 1 January 2018 with a 12-month transition plan.
This guidance is not mandatory or enforceable under law. It is not intended to be restrictive. It describes a way that a medicinal gas manufacturer may operate to demonstrate compliance with the PIC/S Guide to GMP, PE009-13.
This information is provided for guidance only and has been developed on the basis of current knowledge of the subject matter. It should not be relied upon to address every aspect of the relevant legislation.
TGA regulates medicinal gases
Medicinal gases are:
- classified as medicines under the Therapeutic Goods Act 1989 (the Act)
- required to comply with:
- Therapeutic Goods (Manufacturing Principles) Determination
- PIC/S Guide to Good Manufacturing Practice for Medicinal Products PE009-13 (PIC/S Guide to GMP).
Exemptions from regulation
Bulk liquefied medical gases
Bulk liquefied medical gases are exempt from the operation of Part 3-3 of the Act, under Schedule 7, Item 17 (Manufacturing of therapeutic goods).
Medical oxygen cylinders
Oxygen cylinders that have been decant filled, transfilled or cascade filled by a hospital; or an ambulance, fire or rescue service are exempt from the operation of Part 3-3 of the Act, under Schedule 7, Item 20.
Related information
TGA guidance relevant to medicinal gas manufacturing includes:
- Manufacturing medicines
- Data Management and Data Integrity (DMDI) Guidance
- Guidance on release for supply
- Uniform recall procedure for therapeutic goods
Other useful guidance: