美國食品藥物管理境外查核我國食品加工廠衛生安全管理之流程分析   全文下載

Study on the USFDA Foreign Food Facilities Inspection Program toward Taiwan for Food Safety and Sanitation Management Facilities

美國食品藥物管理局（下稱美食藥局）為提升進口食品安全，針對進口國食品工廠進行實地查核，本文將探討美國如何執行我國食品工廠之查核及其查核重點。98至105年美食藥局境外查核我國食品加工廠已累積共210家次，以低酸性罐頭食品類別最多（34%），其次為水產品（21%），該局之查核重點係確認業者產品製程是否符合美國聯邦法典第21篇規定，針對低酸性罐頭食品，其查核重點為確認足以影響產品殺菌方式及商業滅菌效果之項目。由美國境外查核重點不難發現其查核內容與我國食品安全衛生管理法及其相關法令規定具相同精神，包括原物料追溯、人員管理、場所及設施管控、製程危害分析、成品包裝標示與成品追蹤，並著重業者自主管理，確保衛生安全之產品交付予消費者手上。

The purpose of U.S. Food and Drug Administration (U.S. FDA) conduct on-site inspection of foreign food facilities was to ensure the safety of imported foods. The objective of the study was to investigate the U.S. FDA foreign food facility. inspection program From 2009 to 2016, U.S. FDA inspected 210 food facilities in Taiwan, of which the most was low acid canned food (LACF, 34%), followed was seafood (21%). In general, the U.S. FDA inspection was to ensure the facilities complied with the Federal Food, Drug, and Cosmetic Act and relevant regulations of Title 21 of the U.S. Code of Federal Regulation. The U.S. FDA inspection of LACF was to check critical factors and scheduled process which may affect commercial sterility. The items of inspection of foreign food facilities of U.S. FDA were similar to Taiwan, such as the traceability of raw materials and packaging materials, the management of personnel, operation sites, facilities and equipments, the hazard analysis of processing, food labeling, and products tracking. U.S. FDA concerned the food business shall implement sanitation and take their responsibility for food safety of their products before providing to consumers.