Preparing stability data for FDA inspections

If your manufacturer gets inspected and they ask you for your stability data of an OTC, how should they best be presented? 

Are there any standard templates or formats? For e.g. RT and/or accelerated stability looking at % of the active over time?

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  • MicroformulationMicroformulation Member, Professional Chemist
    markfuller@microformulation.com Microformulation.com Microformulation Cosmetic Consulting provides Custom Formulations for both large Commercial accounts as well as smaller entrepreneurs. We can provide Naturally compliant Formulations under the NSF, NPA, Whole Foods and USDA Organic Certifications. BS.Pharm Albany College of Pharmacy, Union University.
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