Why stability studies is performed 12 month beyond the self life of products
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Stability studies is performed beyond shelf life because it gives us a chance to extend the shelf life of the product. for example, our registered shelf life is 24 months, if we have data upto 36 months, an extension of shelf life can be applied.
ICH Q1A(R2), specify that real-time long-term stability data should extend at least to or beyond the proposed shelf life. Extending stability studies by 12 months provides extra assurance. A typical regulatory rule is that the shelf life should not exceed twice the duration covered by actual stability data, and often shelf life proposals are backed by studies 12 months beyond the proposed shelf life to allow for future shelf-life extensions if consistent stability is observed.
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