5. FDA工厂检查指南附件(原料药类).pdfVIP

Appendix C: Checklist 附录C ：审核列表 I: Personnel I ：人员 Measures in place to ensure control of communicable disease. 措施到位，确保控制传染性疾病。 Procedures to ensure no ill persons are in processing area. 有确保无生病的人在生产区域的程序 Required hygiene practices for all persons on duty. 要求所有当值人员按卫生规范操作 Education and training in proper food handling procedures in place. 进行食品操作程序的教育与培训 Supervisors are assigned to ensure compliance with cleanliness procedures. 指定主管进行清洁程序的确认 II: Inspection of Grounds and Sanitary Operations II ：地面和卫生操作的检查 Grounds 地面 Equipment properly stored. 设备安置合理 Litter and waste removed. 垃圾、废弃物已清除 Weeds or grass cut within the immediate vicinity of the plant buildings or structures that may constitute an attractant, breeding place, or harborage for pests. 紧邻厂房或建筑物的杂草要及时修剪，防止其成为昆虫的栖息、繁殖的场所。 Roads, yards, and parking lots are maintained so that they do not constitute a source of contamination in areas where food is exposed. 在任何食物可能暴露的地方，如道路、院落以及停车场等都不能有污染源 Draining areas that may contribute contamination to food by seepage, foot-borne filth, or providing a breeding place for pests are adequate. 凡因渗漏、鞋上的污染物或虫害孽生可能污染的食品区域不得有积水 Systems for waste treatment and disposal are operating in an adequate manner so that they do not constitute a source of contamination in areas where food is exposed. 垃圾处理系统应受控，不得使其成为食品暴露区域的污染源。   Plant Construction and Design 工厂建造和设计 Sufficient space is provided for such placement of equipment and storage of materials as is necessary for the maintenance of sanitary operations and the production of safe food 。 有足够的空间进行设备布置和物料贮存，保证卫生操作以及食品生产的安全。 主要查设备之间预留的空间是否便于生产操作； 厂房预留的空间是否便于物料贮存，不同种或批次物料是否叠放，不同批次物料应有距离区分， 不应紧贴存放。 对于紧凑的空间，在检查时需注意少存放物料。  Take proper precautions to reduce the potential for contamination of food, food-contact surfaces, or food-packaging materials with microorganism