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The measures to prevent cross-contamination should be commensurate with the risks using Quality Risk Management principles to assess and control the risks
before releasing for distribution
including written procedures for the tests and examinations that you conduct to determine whether specifications are met
Wet chemistry requirements of the Quality Control (QC) Laboratory with respect to written procedures and specifications
10.7 - Laboratory Stability Testing audit program The measures to prevent cross-contaminationStability 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
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