(2003; 148 pages)
2. Steps of the procedure
WHO requires information related to the manufacturing and control of the products, and the manufacturing and testing companies. Interested manufacturers provide this information by submitting a product file with the required information, and information as requested about the manufacturing company. In addition to the evaluation of the product information submitted, a manufacturing site inspection(s) may be performed. The WHO reserves the right to terminate the quality assessment procedure of a manufacturer when the manufacturer is not able or fails to provide the required information in a specified time period, or when inadequate information is supplied to complete the quality assessment effectively.