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John O’Neill
Moderator
Post count: 82

Perenniel question within the Stability Community; Regulatory authorities have leaned toward date of manufacture, but there is a strong case for date in chamber if samples have not been under rigorous control (conditions as well as security and documentation). Release data often does double duty as T0 data when less than 30 days go by before going into the chamber. Over 30 days, retesting to set a “Chamber T0” and then paying attention to end of shelf-life vs end of study test points may be an acceptble way to go with scientific justification and approval from your Quality and Regulatory folks.