ABSTRACT

The World Health Organization (WHO), with headquarters in Geneva, Switzerland, is a specialized agency within the Charter of the United Nations with 191 Member States. The WHO was established to assist its Member States in their efforts to promote the health of all people through international cooperation and collaboration, and to give worldwide guidance in the field of health. The WHO Regional Office for the Eastern Mediterranean Region, Alexandria, Egypt, organized an Intercountry Workshop in Amman, Jordan, in early 1993 where the validation of expiry dates of drugs was the main topic of discussion. The WHO Guidelines for Stability Testing of Pharmaceutical Products Containing Well-Established Drug Substances in Conventional Dosage Forms largely coincides with the International Conference on Harmonization Tripartite Guideline with regard to terminology and definitions, the mean kinetic temperature approach, and the majority of the requirements. Guidelines prepared by the WHO should be regarded as technical advice and recommendations to the Member States and national health authorities.