Standard operating procedures for pharmaceuticals good distribution and storage practices

Distribution of pharmaceutical products is an important activity in the integrated supply-chain management. Feeble points in the distribution processes of pharmaceutical products provide viable ground for counterfeit, illegally imported, stolen and substandard medicines to enter the supply chain. To maintain the original quality of pharmaceutical products, every party involved in the distribution chain should comply with the applicable practices, legislation and regulations. Each activity in the distribution of pharmaceutical products should be carried out according to the principles of Good Manufacturing Practice (GMP), good storage practices (GSP) and good distribution practices (GDP). The Ethiopian Food, Medicine and Healthcare Administration and Control Authority is mandated to ensure the availability of quality assured pharmaceutical products to the public. In addition, to ensure the integrity, quality and responsiveness of the supply chain, the authority is required to implement and enforce internal quality management systems in all importers and wholesalers of pharmaceutical products. As part of this effort, the authority has developed model standard operating procedures (SOPs) for pharmaceuticals good distribution practice, good storage practices and other related activities with a view to integrate and standardize internal quality assurance systems of pharmaceutical importers and wholesalers in Ethiopia. Therefore, these model SOPs are prepared to guide pharmaceutical importers and wholesalers to adapt them for their contexts. The pharmaceutical importers and wholesalers are expected to implement the adapted SOPs and display the SOPs in the respective areas at all times. These SOPs define and describe the functional relationships, the work processes, the roles and internal controls that promote efficiency, transparency and accountability