Manufacturers, who contract with analytical laboratories to perform either end product testing or stability studies, or who produce product under contract for other firms are ultimately responsible for the quality of the product and must have copies of all analytical procedures employed and the appropriate documentation to assure their validity on file.
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.
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.
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. Kaybel that when a "new drug" was repackaged, the repacker did not have to obtain pre-market approval of the repackaged product or the firm's repacking procedures. However, the repacker is subject to applicable current good manufacturing practices.
Although stability studies were performed on the dosage unit in the original manufacturer's container, the event of placing the dosage unit into a different storage unit may and often does affect the product's shelf life. 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.
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.
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.
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. By Role. By Location. For Business. Learn more about Business Solutions. Why Food Safety? Small Business Solutions Contact Us.
Learn more about Food Safety. Guides Posters Templates Fact Sheets. Read on to learn the differences between these important dates. What is a best before date? What is a packaging date? What is an expiry date? Other wordings to know Confusion can happen with the different types of dates on packaging due to different wording.
Other types of wording used include: sell by prepared on freeze by manufactured on These different wordings are permitted to be used on food products as long as the label meets regulations and requirements.
Food safety practices Food businesses must ensure that all food received and stored in the food business is checked for best before and expiry dates. The practices under this method include: ensuring items that are received first are used first moving items nearing their expiration date to the front of the shelves clearly labelling and dating containers if food items are not stored in their original packaging checking best before and expiry dates frequently discarding any food items that show signs of spoilage All Food Handlers in a food business, especially kitchen managers and staff, should be trained on these key food safety practices.
If you are registered for the Food Handler Certification course, login here to: start the course or continue your progress take the final exam update your account information Student Login. For Business If you have a Business Account with us, login here to: enrol staff in the Food Handler Certification course track employee progress view your order history and invoices Business Login.
Members get unlimited access to our Resource Library. Login here to: access 'how-to' guides and videos download custom forms and checklists search our food recall feed Member Login. Cancel Need help? Contact us. The retest date is assigned during product design, at the time of initial production, or at a stability testing interval. As a general rule, all new products will be assigned a Retest Date until sufficient data is gathered to establish a shelf life of 36 to 60 months more for some neat materials.
Cerilliant warrants all products will meet the specifications outlined in the COA through the Expiration Date or Retest Date as applicable providing products are stored as stated on the COA or label. This practice is consistent with the regulatory guidance and ensures that Cerilliant products are thoroughly and objectively evaluated for performance not just upon release but throughout the shelf life of the product.
New COAs will be posted upon completion of recertification. Cerilliant warrants the product to meet the acceptance criteria stated on the COA and suitable for quantitative applications unless otherwise stated on the COA when used on or before the stated Retest Date. Qualitative use of the product is not limited by the Retest Date. Solution standards are retested and recertified using a process that involves verification of concentration and purity against the original acceptance criteria.
Neat reference standards are retested and recertified by verifying purity and any changes to the purity factor. Upon successful re-certification a new retest date or expiration date is set for the product.
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