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Posted by: Baktilar Posted on: 07.04.2020

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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

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

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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 Information obtained from old stock, not previously the subject of stability studies, may also be utilized. 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 There must be separate stability studies to support each 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. 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.

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. When accelerated stability studies are performed, one batch may be adequate in order to establish a tentative expiration date.

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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. 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.

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

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 (c). There must be separate stability studies to support each expiration date. STABILITY TESTING (21 CFR ). Expiration Dating and Stability Testing of Solid Oral Dosage Form Drugs Containing Iron Guidance for Industry June may meet stability and expiration dating requirements. 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.

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. It is commonly recommended that stability testing be performed initially, than every three months for the first year, then every six months for the second year, and then annually thereafter.

However, more frequent testing near the end of the anticipated expiration date is often likely to give better information about the actual stability of the finished product. 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. As long as there is at least one test performed annually, this approach can be quite satisfactory.

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If a product was stored under controlled conditions, those actual conditions temperature and humidity should be recorded. Merely stating that a product was stored at room temperature is not sufficient for purposes of determining stability. Likewise, repackers who rely on stability studies performed by the manufacturer must have copies of all analytical data necessary to support the expiration dating period.

Although specific methods are critical to determine product stability, they do not have to employ any specific technique.

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The use of quantitative analysis, where limits are known, such as thin layer chromatography, may be satisfactory. While many USP tests are specific for the drug or its degradates and may be used for stability testing, some USP monographs do not incorporate stability indicating tests. Additionally, it may be unreasonable to expect a manufacturer to develop specific methodology for each component of some multi-component drugs containing ingredients of botanical origin such as benzoin, Peruvian balsam or tolu balsam.

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The requirement that stability testing be performed in the same container-closure system as that in which the drug product is marketed has been subject to interpretation. The courts ruled in U. However, the repacker is subject to applicable current good manufacturing practices. It is the policy of the Center for Drugs and Biologics to allow repacking into container-closure systems that can be demonstrated to be at least as protective or more protective than the original system without performing new stability studies prior to marketing.

FDA regulations require drug applicants to provide stability testing data with a proposed expiration date and storage conditions when they submit an application for FDA approval of their drug. The results of such stability testing shall be used in determining appropriate storage conditions and expiration dates. The written program shall be followed and shall include: (1) Sample size and test intervals based on statistical criteria for each attribute examined to assure valid estimates of stability;. Revisions to 21 CFR Part , Current Good Manufacturing Practices for Finished Pharmaceuticals (CGMP) introduced requirements concerning expiration dating (21 CFR ) and stability testing.

Satisfactory comparison of container-closure systems may be done by several methods, i. Stress testing refers to testing the product after storage under exaggerated conditions. This will usually involve high temperature and high humidity. It is also current policy to allow firms to repackage solid dosage units from plastic containers into glass containers because glass has been shown to be a superior moisture and gas barrier.

This policy does not apply to liquid drugs because of pH problems resulting from the alkaline nature of glass.

Cosmetic expiry date - shelf life - stability testing

Policies relating to the expiration dating of unit dose repackaged drugs may be found in Compliance Policy Guide b. This also does not apply to repacking from bulk containers. When the same product is marketed in more than one size, e.

This indicates that the smallest marketed container is the most critical in terms of the container properties contributing to product degradation. Thus, moisture or oxygen permeation through a 4 oz bottle is more critical than through a 16 oz bottle of similar construction.

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For this reason, when studying stability of the product marketed in several sizes of similar containers, testing of the smallest container size is imperative to be in compliance with CGMPs. While we recommend that all other container sizes be subjected to stability testing, the fact that some may not is not necessarily a violation of CGMPs.

Products formulated to contain preservatives to inhibit microbial growth should be monitored throughout their shelf life to assure the effectiveness of the preservative system. Once a minimally effective level of preservative is established, chemical testing for the preservative s may be performed.

The preservative system should be monitored at the same stability testing times as other ingredients are monitored. Drug stability requirements for otc drug storage conditions recommended storage conditions and effective stability testing is not the worst case evaluation technique. Chpa guidelines on testing conditions as the manufacturer's expiration date of drug. Download this Document [ This is much more than just the document.

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Requirements for expiration dating and stability testing

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Regulatory requirement related to Stability Testing The expiration dating period for a reprocessed batch should not exceed that of the parent batch, and the expiration date should be calculated from the original date of Regulatory Requirements Related to Stability Testing. Stability testing is defined as required to establish the fda thinking about expiration date. From 12 months after reconstitution or they may. Cfr a general, after reconstitution or a labeled date. Labvantage stability studies on stability study by the drug product. USP Compounding Standards and Beyond-Use Dates (BUDs) June 3, Comparing BUDs between the official and the revised The revised chapter addresses Compounded Nonsterile Preparations (CNSPs) requiring shorter BUDs and BUDs for CNSPs that may be extended (e.g. CNSPs with a USP-NF monograph or stability information).

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