"The initial date of storage should be considered t0 and stability time points should be defined as a date with respect to t0." WHO ECSPP TRS 1010 Annex 10 Stability testing of active pharmaceutical ingredients and finished pharmaceutical products 201805
另见识林相关讨论：稳定性研究的起始考察时间如何确定？
ICH中关于稳定性考察批次选取的规定如下，要求至少三批，并未要求必须是工艺验证批次，批次满足相关条件即可。
2.2.3. Selection of Batches
Data from stability studies should be provided on at least three primary batches of the drug product. The primary batches should be of the same formulation and packaged in the same container closure system as proposed for marketing. The manufacturing process used for primary batches should simulate that to be applied to production batches and should provide product of the same quality and meeting the same specification as that intended for marketing. Two of the three batches should be at least pilot scale batches and the third one can be smaller, if justified. Where possible, batches of the drug product should be manufactured by using different batches of the drug substance.
Stability studies should be performed on each individual strength and container size of the drug product unless bracketing or matrixing is applied.
Other supporting data can be provided.
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