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Any drug product intended for reconstitution and not bearing an expiration date for the unreconstituted product and another expiration date for the product after reconstitution is considered to be out of compliance with 211.137 (c).There must be separate stability studies to support each expiration date.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).The expiration dating period used would then be the sum of that justified individually at each storage condition.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.Combining data compiled at room temperature and at accelerated temperature is possible to justify an expiration dating period of over two years.This can be done, as an example, by taking a sample product that has been at room temperature for one year and subjecting that sample to accelerated temperature conditions.
Information obtained from old stock, not previously the subject of stability studies, may also be utilized.There may be other considerations but in its simplest form, the expiration date on the medical device is based on the length of time the device performs as designed.Integrity testing plays an important role in verifying the maintenance of sterility and should be included in a shelf-life protocol.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.
As long as there is at least one test performed annually, this approach can be quite satisfactory.