TGA Good Manufacturing Practice (GMP) Guidelines for Medicinal Products - Annexes
Annex 1 - Manufacture of
sterile medicinal products
Annex 2 - Manufacture of
biological medicinal substances and products for human use
Annex 3 - Manufacture of
radiopharmaceuticals
Annex 6 - Manufacture of
medicinal gases
Annex 7 - Manufacture of
herbal medicinal products
Annex 8 - Sampling of
starting and packaging materials
Annex 9 - Manufacture of
liquids, creams and ointments
Annex 10 - Manufacture
of pressurized metered dose aerosol preparations for inhalation
Annex 11 - Computerized systems
Annex 12 - Use of ionizing radiation in the manufacture of medicinal products
Annex 13 - Manufacture
of investigational medicinal products
Annex 15 - Qualification
and validation
Annex 16 - Qualified
person and batch release [This Annex is not adopted by the PIC/S and Australia]
Annex 17 - Real time
release testing and parametric release
Annex 18 - GMP guide for
active pharmaceutical ingredients [This Annex no longer exists]
Annex 19 - Reference and
retention samples
