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. |