Stability studies ongoing testing

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. 

All hydrocarbon fire mechanisms and estimates will be affected to some extent by flame stability features such as varying fuel composition as lighter constituents are consumed, available ambient oxygen supplies, ventilation parameters, and wind effects. Studies and experimental tests are ongoing by some research institutes and industries to provide more precise modeling techniques into the release of gas, its dispersion, fire, and explosion effects. 

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