Ongoing stability testing

Many of the steps involved in a risk-based approach are comparable to the standard transfer paradigm, but the risk-based approach requires significantly more upfront activities to better understand both process and methods. This increased investment increases both the likelihood of successful transfer, the risk of observing a step-change for ongoing stability testing, which could affect shelf-life of the product and the likelihood of future OOS investigations. 

Ongoing production, ongoing stability tests. Batches representative of production placed on confirmatory stability tests at regular intervals. 

Even when the shelf life has been established stability testing should be continued. This is called ongoing stability testing. A practical approach is to investigate the active substance at the end of the shelf life. It can be questioned whether the preparation always complies with the end-of-shelf life requirements during routine production. Small deviations in the production process, starting materials, or packaging materials may influence the stabihty of the preparatimi. 

Ongoing stability of toxicology test articles or stability studies of new toxicology formulations... 

The manufacturer must carry out on-going real-time stability studies to substantiate the expiry date and the storage conditions previously projected. The data needed to confirm a tentative shelf-life must be submitted to the registration body. Other results of ongoing stability studies are verified in the course of GMP inspections. To ensure the quality and safety of products with particular reference to degradation, national health authorities should monitor the stability and quality of preparations on the market by means of a follow-up inspection and testing programme. 

Where stability data show a trend towards potency loss or degradant increase under accelerated conditions, it is recommended that historical accelerated stability data from a representative prechange batch be submitted for comparison. It is also recommended that under these circumstances, all available long-term data on test batches from ongoing studies be provided in the supplement. Submission of historical accelerated and available long-term data would facilitate review and approval of the supplement. 

A reduced stability database at submission time (e.g., 6 months accelerated and 6 months long-term data from ongoing tests) may be acceptable in certain justified cases. Refer to the ICH guidelines QIC for details. 

A formal testing program should be established to assess the stability characteristics of APIs. The results of such testing should be used to determine appropriate storage conditions and retest or expiration dates. The testing program should be ongoing and include ... 

To compare different polymers with respect to their chemical stability, the Fenton test is widely applied in fuel cell membrane research. In these tests, membrane samples are immersed in hydrogen peroxide solution containing a small amount of Fe " ", e.g., iron(lI)sulfate. In the presence of the metal ion, the decomposition of hydrogen peroxide is accelerated. The ongoing reactions are very complex, and several reactive intermediates are formed. Just as an example and demonstrating the catalytic nature, the following partial reactions of the so-called Haber-Weiss mechanism are highlighted, as shown in (6.28)-(6.31) [49, 50]. 

---