Drug stability expiration dating

Drug stability expiration dating

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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.

The expiration dating period used would then be the sum of that justified individually at each storage condition.

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

Absence of an Expiration Date 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. Exemptions OTC drug products meeting the exemption of 211.137 (g) may utilize accelerated testing programs to support the requirement that they are stable for at least three years.

Information obtained from old stock, not previously the subject of stability studies, may also be utilized. Products Intended for Reconstitution 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).

This is acceptable since it is not the purpose of an accelerated test to determine batch uniformity but rather to test for kinetic degradation.

The use of accelerated testing data to establish a tentative expiration dating period of greater than three years is discouraged when it is based solely on accelerated data.

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Written Stability Testing Program The absence of a written protocol for stability testing is cause to initiate regulatory action against the product and/or the responsible firm. Supportive Stability Data Initial stability testing by accelerated testing may be performed on a batch smaller than the normal production size as long as the batch is produced by similar equipment as would be used for regular production.

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