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SFDA: Guidelines for Stability Testing of API and Finished Pharmaceutical Products


The purpose of stability testing is to provide evidence of how the quality of an API or FPP varies with time under the influence of a variety of environmental factors such as temperature, humidity and light.

As a result of stability testing a re-test period for the API (in exceptional cases, e.g. for unstable APIs, a shelf-life is given) or a shelf-life for the FPP can be established and storage conditions can be recommended.

The current version Version is 3.4 and are adapted from International Conference on Harmonisation (ICH) on stability guidelines and the World Health Organization (WHO) guidelines on stability testing of active pharmaceutical ingredients and finished pharmaceutical products.


These guidelines seek to exemplify the core stability data package required for registration of active pharmaceutical ingredients (APIs) and finished pharmaceutical products (FPPs) in the Gulf Cooperation Council (GCC) States. However, alternative approaches can be used when they are scientifically justified.


These guidelines apply to new and existing APIs and address information to be submitted in original and subsequent applications for marketing authorization of their related FPP for human use.


It is recommended that these guidelines should also be applied to products that are already being marketed, with allowance for an appropriate transition period, e.g. upon re-registration or upon re-evaluation.


Click this LINK to know more about stability data package required for registration of active pharmaceutical ingredients (APIs) and finished pharmaceutical products (FPPs) in the Gulf Cooperation Council (GCC) States.



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