TGA GMP Guidelines for Medicinal Products - Annexes

Sathyanarayana M.Sc.
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TGA Good Manufacturing Practice (GMP) Guidelines for Medicinal Products - Annexes

TGA GMP Guidelines for Medicinal Products - Annexes
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Contents 

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 4 - Manufacture of veterinary medicinal products other than immunologicals [This Annex is not adopted by the TGA]

Annex 5 - Manufacture of immunological veterinary medical products [This Annex is not adopted by the TGA]

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 14 - Manufacture of products derived from human blood or human plasma [This Annex is not adopted by the TGA]

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

Annex 20 - Quality risk management

Glossary



TGA GMP Guidelines for Medicinal Products - Annexes

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