ABSTRACT
The World Health Organization (WHO) is an intergovernmental specialized agency of the United Nations with 193 member states. Regarding pharmaceutical and biological products, WHO has the global mandate to develop, establish, and promote quality, safety, and efficacy standards and codes of good practices for all medicinal products. The International Non-proprietary Names identifies pharmaceutical substances by unique, globally recognized names. In 1998, WHO began a special project to assist in implementing of GMP in member states with limited resources. In 1999, WHO published guidelines on the detection and prevention of counterfeit and substandard products. WHO was requested to encourage the international community to formulate self-regulatory guidelines for good information practices and to develop a model guide for member states. The WHO guidelines on stability testing of pharmaceutical products containing well-established drug substances in conventional dosage forms cover all four climatic zones.
