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The simplest and safest course of action is to set down the annual studies in full commercial pack, but some companies use the justification based on a statement in the WHO Stability Guidance that infers that commercial packs that don’t influence stability of the product can be omitted. This can save time and resources if you usually pull the samples before they go out for final packaging. Take that course only with the blessing of your QA and Reg affairs folks and better still, include this course of action for annual commercial studies in your registration (along with the WHO justification) to get approval up front and in writing.
What do the rest of our Stability colleagues think?
