THE GCC ( Cooperation Council for The Arab States of the Gulf )
GUIDELINES ON STABILITY TESTING OF PHARMACEUTICAL PRODUCTS :
The guideline seeks to exemplify the core stability data package for drug products, but leaves sufficient flexibility to encompass the variety of different practical situations that may be encountered due to specific scientific considerations and characteristics of the materials being evaluated. Alternative approaches may be used when there are scientifically justifiable reasons.
The purpose of stability testing is to provide evidence on how the quality of a drug product varies with time under the influence of a variety of environmental factors, such as temperature, humidity and light, and to establish a shelf-life for the drug product and recommended storage conditions.