About this guideline
Overseas effective date: 17 Sep 2004
Categories: Quality | Stability
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TGA annotations
The TGA acknowledges this Guideline has been withdrawn by the ICH, as set out in Explanatory Note on the Withdrawal of ICH Q1F from the ICH Website (pdf,111kb)(link is external).
This guideline remains adopted by the TGA because a significant portion of Australia lies in climatic zones III and IV. The guideline requires at least 12 months stability testing at 30°C/65% rh, 6 months testing at 40°C/75% rh, 3 months testing at 50°C (in certain circumstances) and 3 months testing at 25°C/80% rh (for solid dosage forms in water-vapour permeable packaging). However, the TGA allows some alternatives to these requirements, as follows:
- Testing at 50°C is not required.
- Testing at 25°C/80% rh is not required if the product shows satisfactory stability during long term testing at 30°C/65% rh.
- If a product does not show satisfactory stability for at least 3 months at 40°C/75% rh, there are several acceptable options:
- argue that, as the container is designed to provide a barrier to water vapour, further investigation of stability under conditions of high humidity is not necessary; or
- demonstrate, by testing at least 3 batches, that the product is stable for 3-6 months at 30°C/75% rh; or
- package the product in a container/closure system that is less permeable to water vapour; or
- label the product "Store below 25°C".
- If a product is labelled "Store below 25°C", the TGA will accept:
- long term stability testing at 25°C/60% rh in place of 30°C/65% rh; and
- 6 months testing at 25°C/80% rh or 30°C/65% rh (at least 3 batches) in place of 40°C/75% rh. Nevertheless, initial testing of the product should be conducted in accordance with the guideline, ie, at 30°C/65% rh and 40°C/75% rh. If stability is inadequate under these conditions (and, if tested, the alternative condition of 30°C/75% rh) the use of more protective packaging should be considered before the option of labelling the product "Store below 25°C".
Generally, if a product shows satisfactory stability for at least 3 months at a high humidity test condition (40°C/75% rh, 30°C/75% rh, 30°C/65% rh or 25°C/80% rh, as appropriate), then the TGA will consider a shelf life of up to 2 years, subject to satisfactory long term stability data. If a product is stable for 6 months under these conditions then a shelf life in excess of 2 years will be considered. [Any of these four storage conditions would be acceptable for high humidity testing of a product labelled "Store below 25°C", but only 40°C/75% rh or 30°C/75% rh would be acceptable for a product labelled "Store below 30°C".]
For more information see International scientific guidelines adopted in Australia.
Where EU guidelines adopted in Australia include references to EU legislation (including EC Directives and Regulations), the requirements contained in the referenced EU legislation are not applicable to the evaluation of medicines by the TGA.