10.7 - Laboratory Stability Testing audit program Wet chemistry requirements of the

Wet chemistry requirements of the Quality Control (QC) Laboratory with respect to written procedures and specifications

You must identify and use an appropriate scientifically valid method for each established specification for which testing or examination is required to determine whether the specification is met

before releasing for distribution

or contact surfaces by maintaining good

10.7 - Laboratory Stability Testing audit program Wet chemistry requirements of theStability 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