Ministry of Food and Drug Safety 국민 안심이 기준입니다 YOUR SAFETY IS OUR STANDARD

Ministry of Food and Drug Safety 국민 안심이 기준입니다 YOUR SAFETY IS OUR STANDARD

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[Press Release, July 27] Reinforced Management of Vaccines Storage and Shipment from production to administration
  • Registration Date 2020-08-06
  • Hit 12811
[Press Release, July 27, 2020 / unofficial translation] Reinforced Management of Vaccines Storage and Shipment from production to administration - Development of the“Guideline on the Management of Vaccines Storage and Shipment” - □ The Ministry of Food and Drug Safety (MFDS; Minister Lee, Eui-kyung) and the Korea Centers for Disease Prevention and Control (KCDC; Director General Jeong, Eun-kyeong) developed the “Guideline on the Management of Vaccines Storage and Shipment” to advise on the management method needed to maintain optimal quality of vaccines among others. ○ The guideline puts forward recommendations related to the management of temperature, which is important to ensure the quality of vaccines during their the production, distribution, and the application of vaccines, and stipulates statutory requirements for the management of vaccine by manufacturers, importers, and wholesale distributors. - Furthermore, it provides detailed guidance on ▲the management of storage equipment and temperature; ▲measures to be taken in the events of vaccine storage emergency; and ▲checklist for the self-inspections by the medical institutions entrusted with the National Immunization Program, among others, to ensure safe vaccinations at public health centers and medical institutions. □ The MFDS and the KCDC expressed their commitment to ensuring the safe administration of vaccines from the production to the application of vaccines for the people by competently managing their storage and shipment. ○ More information is available from the MFDS homepage (www.mfds.go.kr) → laws and regulations/resources → Guidelines for government employees/Information for civil petitioners. [ Attachment ] Contents of the Guidelines on the Management of Vaccines Storage and Shipment Ⅰ. Overview and Glossary √Describe background and purpose of the guideline (e.g. the importance of vaccines storage and shipment by the manufacturer, the importer, and the wholesale distributor and medical institutions) √Define terms one must know when dealing with vaccines (e.g. manufacturing manager, import manager, potency and qualification tests) Ⅱ. Vaccines storage management by manufacturers, importers and wholesale distributors √Provide general information on storage tasks, standards for storage facilities, and storage environment management √Suggest precautionary measures related to checklist for warehousing vaccines and the maintenance of appropriate temperature Ⅲ. Vaccines shipment management by manufacturers, importers and wholesale distributors √Suggest methods for regular maintenance of vaccine shipment containers and equipments (e.g. establishment of standards, inspection and calibration of equipment) √Suggest precautionary measures (e.g. maintaining appropriate temperature during vaccine shipment and storing lot release certificates) Ⅳ. Vaccines storage management by medical institutions √Provide checklist for vaccination clinics √Suggest designation of vaccine coordinators and their specific responsibilities √Advise on how to manage vaccine inventory √List matters related to planning vaccine storage and handling √Make recommendations on how to choose vaccine storage equipment (refrigerator/freezer) and manage temperature √Describe procedures for the maintenance of vaccine storage equipment (e.g. cleaning the interior of each unit) √Suggest precautionary measures regarding the use of vaccine storage equipment (e.g. power protection) √Provide checklist for vaccine administrations (e.g. checking the expiration date) √ Advise on how to handle vaccine storage equipment malfunctions
Attached File
  • 7.27 (보도참고) 백신 품질관리를 위한 가이드라인_영문본_수정F.pdf Download preview

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