Expiration dating and stability testing

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expiration dating and stability testing
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One of the steps toward achieving cannabis compliance for is by assessing shelf life. Stability studies are required in GMP and are vital to any quality assurance system. Expiration dates will need to be printed onto product packaging in order to protect consumers and your company by ensuring the quality of a product through a specific time.
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Understandably, the FDA and other regulatory agencies require this data as part of a registration application for the drug substance or product. Usually, pharmaceutical companies begin stability studies during clinical trials and manufacturing and some even continue these studies after gaining approval. Pharmaceutical companies arrive at optimum storage conditions and the expiration date of a drug substance or drug product which can be seen commonly on drug labels after collecting stability data over months to years.

When submitting pharmaceutical products to the FDA for approval, testing must be performed to ensure they are effective and ultimately safe for public use. Stability testing helps ensure international regulation requirements are met and includes downstream analytical testing and stability storage stages. These tests measure the quality of a product after exposure to environmental factors such as light, heat, and humidity. Any product changes recorded, whether microbiological, chemical, or physical, are then assessed for impact on the overall product integrity.

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