Sub-Part J - Laboratory Operations

10.7 - Laboratory Stability Testing

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Stability testing must be performed to determine the shelf life of a new product from date of manufacture, in an unopened state , from which the expiry date can be calculated,  to determine the period after opening or best before date when opened, or with simulated in-use, and to re-confirm on an annual routine basis the shelf life of an existing drug or supplement product using ICH principles and guidelines.

Expiration date icons created by Freepik - Flaticon
Sky blue skin cream jar purple inside with lid open and 12M written on the side to say 12 months expiry period after opening