Stability data package types

Table 1 Stability data package types to support a postapproval change...

The five types of stability data packages are outlined in Table 6. 

Example 5 Multiple-Factor Stability Study A well-known example introduced by Shao and Chow [19] is used to illustrate the application of shelf life calculations for a multifactor case. A stability study was conducted on a 300-mg tablet of a drug product to establish the shelf life for each of the two types of packages used for this product bottle and blister. The results are shown in Table 24. Each type of package includes five batches. The tablets were tested for potency at 0, 3, 6, 9,12, and 18 months. Determine the shelf life based on these stability data. 

USP describes Type I glass as highly resistant borosilicate glass, and usually used for packaging acidic and neutral parenteral preparations. Also, where stability data demonstrates their suitability. Type I are used for alkaline parenteral preparations. ... 

Chcmge of type of container Major (DRA-3) Stability data to support the use of the new packaging material C2(f)... 

The containers must correspond to those reflected in Annexure 1 (presentation), 10 (stability data) and 11, the description of the packaging procedure, except that the description given under the presentation in Annexure 1 need not include the specific type of material of the container (e.g., Bottles of 100 should suffice). Recently applicants have sometimes been requested to specify the con-... 

The studies are carried out on the drug in each package type in which it is sold in Canada Stability data originating from the foreign fabricator are acceptable provided that they are procured on a regular basis, periodic review confirms their accuracy and it is established that the products are not affected by transportation. 

When the PVC unzippers, it discolors and becomes brittle. To prevent this dehydrochlorination reaction, heat stabilizers are added. Lead stabilizers are effective and a major type of heat stabilizer. Data from 2003 [24] shows lead stabilizers to represent more than 50% of the world PVC stabilizers, but less than 20% in the U.S. where tin stabilizers predominate. The use of lead stabilizers is on the decline and being phased out due to concerns about the health effects of lead. Nonetheless, the news occasionally reports that lead has been found in a toy or other PVC article imported from a country such as China. The source of lead is likely due to the stabilizer. Another type of heat stabilizers is the mixed metal packages which are based upon mixtures of different... 

Another consideration is whether zero-time data for a batch in one container-closure may be used for the same batch in a different container-closure system. This would depend on the amount of time between packaging of the product and zero-time as well as the stability profile of the product. The data generated for zero-time for a batch in one type of container-closure are usually also used to evaluate the same batch in the same container-closure under different storage conditions. 

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