![]() ![]() The expiration dating period used would then be the sum of that justified individually at each storage condition. 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. Combining data compiled at room temperature and at accelerated temperature is possible to justify an expiration dating period of over two years. 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. This is acceptable since it is not the purpose of an accelerated test to determine batch uniformity but rather to test for kinetic degradation. When accelerated stability studies are performed, one batch may be adequate in order to establish a tentative expiration date. ![]() Since a dosage form is a complex unit and there are continued variables in the production process, such as change in personnel, raw material lots and suppliers, and equipment, it is imperative that stability studies are not limited only to initial production batches but a portion of annual production batches be the subject of an ongoing stability program. Generally, the placing of three initial batches into the long term stability program is considered minimal to assure batch uniformity for establishing an expiration date. 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. The absence of a written protocol for stability testing is cause to initiate regulatory action against the product and/or the responsible firm. There must be separate stability studies to support each expiration date. Information obtained from old stock, not previously the subject of stability studies, may also be utilized.Īny 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). 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. 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. ![]() The CGMPs were purposely written broadly to allow for such unique differences. Because of the uniqueness of each drug product, it is virtually impossible to provide one set of rules that can apply to all situations. 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. Publishing of 21 CFR Part 211 - 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. ![]() ITG SUBJECT: EXPIRATION DATING AND STABILITY TESTING FOR HUMAN DRUG PRODUCTS ![]()
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