All relevant clauses of the PIC/S Guide to GMP apply to the manufacture of medicinal gases; however, specific guidance regarding the interpretation of certain GMP requirements is provided herein. Where this guide does not provide any commentary regarding interpretation, it is expected that the manufacturer fully comply with those requirement(s), without further interpretational guidance.
In general, you should follow the principles of Part I of PE009-13, and in addition, all annexes relevant to the manufacture of medicinal gases.
You should meet the requirements of the following Annexes:
Annex 6 (Manufacture of Medicinal Gases)
Annex 11 (Computerised Systems)
Annex 15 (Qualification and Validation)
Annex 20 (Quality Risk Management) NB this is a voluntary annex; however, the principles outlined in the annex are applicable to the manufacture of therapeutic medicinal gases
The Department of Health and Aged Care acknowledges First Nations peoples as the Traditional Owners of Country throughout Australia, and their continuing connection to land, sea and community. We pay our respects to them and their cultures, and to all Elders both past and present.