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ARGOM Appendix 2: Guidelines on quality aspects of OTC applications

Version 1.1

30 May 2014

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11. Checklist for submission of stability data

Use of the following checklist is entirely optional, but may reduce delays and requests for further information during the evaluation. This checklist should not be submitted with the application.

Ensure that you:

have enough stability data to support a shelf life of at least 12 months
present stability data on at least two batches of each strength of the product (unless bracketing and matrixing are applied – see above)
specify the formulation(s) used in the study, and state which batches are identical to those proposed for registration in Australia
provide details of batch numbers and date of manufacture of each batch, as well as the dates on which they were placed on the stability trials
state whether the batches used in the study were laboratory, pilot or production batches (and specify the size of each batch - e.g. 50 kg or 100,000 tablets)
clearly describe the packaging used in the study and confirm whether it is identical to the pack that will be used in Australia
indicate the orientation of the containers (e.g. upright, inverted) in the case of products for which orientation could influence stability
specify the temperature, lighting and humidity conditions applied during the study, and confirm that these were in line with the relevant ICH requirements (or provide justification for any differences)
fully describe all test methods (and provide validation data where relevant)
ensure that all appropriate chemical and physical parameters are monitored, as detailed under 'Appropriate Tests', above
include stability studies under conditions of high or low humidity where appropriate (see under relevant headings above)
provide quantitative results where possible
provide results from sufficient time stations to allow assessment of any trends in the parameters
for dissolution testing, provide results for individual dosage units (or both mean and range)
provide explanation/assessment where there are obvious alterations in the characteristics of the product
provide explanation/assessment where there is a lack of balance between the formation of degradation products and the loss of the active ingredient
provide an observational or statistical analysis to support any extrapolation (where the long term data do not cover the whole of the proposed shelf life) and ensure that the extrapolation does not exceed the amount permitted under the ICH guidelines
provide a post-approval stability protocol and commitment (as described above) if the shelf life has not been confirmed with stability data on sufficient production batches covering the whole period.

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