Overview of regulatory guidelines for stability study of pharmaceuticals

The safety, efficacy and quality of a pharmaceutical product plays a crucial role in product development, stability study ensures the following about the product.  Shelf life of a product is consider for its acceptance and approval. These stability studies are conducted by following guidelines issued by international regulatory agencies such as ICH, WHO etc. These guidelines provide a plan to conduct the stability study, various methods are involved in performing stability studies. The environment plays an important role in quality of a product, the stability studies helps to retain product specified limits throughout its period of storage and use. Which helps in determined its shelf life. In this overview the guidelines and trends of stability testing are briefly described.