Sterility expiration dating

Merely stating that a product was stored at room temperature is not sufficient for purposes of determining stability.

The USP defines controlled room temperature as being between 15 and 30 C (59 and 86 F).

Nonetheless, testing at least annually is considered minimal for compliance with CGMPs.

Some firms have chosen, for economical purposes, random dates to test all stability samples of a given product.

The CGMPs were purposely written broadly to allow for such unique differences.

The absence of an expiration date on any drug product packaged after September 29, 1979, except for those drugs specifically exempt by 211.137 (e), (f), and (g), is cause to initiate regulatory action against the product and/or the responsible firm.

USP is a not-for-profit, science-driven organization that has an established process for convening independent experts in the development and maintenance of healthcare quality standards.

The process is public health focused, leveraging current science and technology, and draws on the expertise of scientists and healthcare practitioners while providing opportunities for public input from stakeholders throughout the standards’ progress.

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We do not believe it is reasonable to perform accelerated testing at very high temperatures for a very short time and expect to extrapolate results to a very long expiration dating period since the actual mechanism of degradation at high temperature may be different than at room temperature.A breach of package integrity most often occurs due to some event.Multiple distribution cycles, repeated handling in inventory, and exposure to various environmental conditions are some points at which events may occur resulting in damage to the protection a package provides a product.With some sterilization methods, polymers or other components may suffer long term affects that shorten the normal shelf-life.These are things that should be considered during the developmental stages of the product and package system.

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