Requirements for expiration dating and stability testing

Publishing of 21 CFR Part - Current Good Manufacturing Practice for Finished Pharmaceuticals established requirements concerning the expiration date on a drug product and stability testing to assure the appropriateness of that date. Each drug product may be a unique article because of, for instance, differences in 1 chemical and physical properties of the active ingredients or the excipients, 2 manufacturing procedures, 3 formulations, 4 containers and closures, 5 proposed storage conditions, and 6 the stability of the article to maintain its quality or purity through the use of antioxidants or preservatives. Because of the uniqueness of each drug product, it is virtually impossible to provide one set of rules that can apply to all situations. 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, , except for those drugs specifically exempt by OTC drug products meeting the exemption of
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Designing Phase-Appropriate Stability Study Programs for Drug Substances and Drug Products

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21 CFR § - Expiration dating. | CFR | US Law | LII / Legal Information Institute

The pressure to develop compliant and cost-effective drug stability testing programs is enormous. And they want them to stay on shelves longer. So the cost of getting ANY part of your stability testing program wrong can result in significant wasted resources, delayed approvals and lost revenue. For example, by miscalculating an expiration date you could remove product too early and reduce potential revenue or leave product on the shelf too long and impact patient health. If the stability demons have you staying up at night, FDAnews and noted stability expert Charity Ogunsanya of Pharmabiodevice Consulting, have you covered. In this 6-hour virtual conference CD and transcript set Ms. Ogunsanya provides in-depth training on protocol design, testing, storage, data management, trending and expiration dating extrapolations for approved products or new or existing products in the IND or NDA stage.
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FDA Draft Guidance on Expiration Dating of Unit-Dose repackaged Solid Oral Dosage Forms

The U. The FDA states that this action was taken in response to " an increasing demand in various health care settings for solid oral dosage form drug products repackaged into unit-dose containers, which hold a quantity of drug for administration as a single dose. The increase in unit-dose repackaging has led to questions regarding stability studies and appropriate expiration dates for these repackaged products ". In addition, once final, it will supersede Compliance Policy Guide
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Courtesy of Getty Images. As Seth explained, for pharmaceuticals, the most common violations in warning letters were failure to:. The most common violations in warning letters for medical devices were failure to establish and maintain procedures for:.
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