Guidelines for Stability Testing of Active Pharmaceutical Ingredients and Finished Pharmaceutical Products(SFDA)

Guidelines for Stability Testing of Active Pharmaceutical Ingredients and Finished Pharmaceutical Products

The stability studies of pharmaceutical products are one of the very important parameter for development of new drugs as well as new formulations. The shelf-life prediction is a major role for the pharmaceutical product development of all the dosage forms and also it is utilized to determine the particular storage conditions and to suggest label instructions. Stability studies of pharmaceutical products ensuring the maintenance of product quality, safety and efficacy throughout the shelf life are considered as prerequisite for the acceptance and approval of any pharmaceutical products. These studies are required to be conducted in a planned way following the guidelines issued by ICH, WHO or other agencies.

These guidelines 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. Further guidance can be found in International Conference on Harmonisation (ICH) guidelines and in the WHO guidelines on the active pharmaceutical ingredient master file procedure. 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. 

SAUDI FDA Guidelines for Stability Testing