Guideline on Stability Testing: I 6.2.10.2 Stability Testing of Existing Active Substances and Related Finished II 5.2.10.2 Products III 4.3.2 product guidelines Guideline name Guideline identifier Referenced in the ARGCM Part Section Note for Guidance on Impurities in I 6.2.7.3 New Drug Products (Revision 2) (ICH Topic Q3B(R)) Note for Guidance on Quality of I 6 Herbal Medicinal Products II 5 III 4 Biotechnology guidelines substance and medicinal product guidelines Guideline name Guideline identifier Referenced in the ARGCM Part Section Note for Guidance on Minimising IV 20.1 the Risk of Transmitting Animal Spongiform Encephalopathy Agents via Human and Veterinary V 3 Medicinal Products* *Contains an Australian specific notation
Guideline on Stability Testing: Stability Testing of Existing Active Substances and Related Finished Products I 6.2.10.2 II 5.2.10.2 III 4.3.2 product guidelines Guideline name Guideline identifier Referenced in the ARGCM Part Section Note for Guidance on Impurities in New Drug Products (Revision 2) (ICH Topic Q3B(R)) I 6.2.7.3 Note for Guidance on Quality of Herbal Medicinal Products I 6 II 5 III 4 Biotechnology guidelines substance and medicinal product guidelines Guideline name Guideline identifier Referenced in the ARGCM Part Section Note for Guidance on Minimising the Risk of Transmitting Animal Spongiform Encephalopathy Agents via Human and Veterinary Medicinal Products* *Contains an Australian specific notation IV 20.1 V 3
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