Inspection Manual for Inspectors

The government of Ethiopia has been working to strengthen the regulatory system at national level. Providing comprehensive regulation of all matters related to safety and quality of pharmaceutical products is crucial. The regulation of medicines involves, among other things, inspection of medicine outlets which include manufacturers, importers, wholesaler, distributors and retail outlets. Conducting inspection activities is important in ensuring that medicines and other health products circulating on the market meet the prescribed safety and quality standards. To achieve this goal, inspectors need to be provided with sufficient knowledge and skills, working tools, and ample time to exert their expertise in observing, investigating, and reaching conclusions on the quality of medical products. This manual has been prepared to guide inspectors in preparing for and performing various types of inspection activities. It also serves as reference document for inspectors before, during and after inspections. The manual highlights general conditions and other pertinent requirements that are necessary for carrying out medicine outlets inspections